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  • February 21, 2019 11:57 AM | Anonymous member (Administrator)


  • February 14, 2019 9:18 PM | Anonymous member (Administrator)



    Overview

    The purpose of this position is to lead and manage product transfers for internal and external opportunities at Bausch & Lomb Tampa.  This includes management and maintenance of existing external customers, new manufacturing business opportunities, as well as internally developed product transfers. This position provides quotes to customers for all project requests and also manages the supply agreement approval and renewal process. This position is also responsible for the process engineering / validation of new and improved capital equipment.

    Responsibilities

    Management of Process Engineers to support project activities and site goals.  Employee development, training, performance reviews, etc.

    Manage internal and external technology transfers and maintenance of business projects. Major technology transfer projects are planned for and executed over a period of 2-3 years.

    Manage process engineering (engineering studies, process development, PV's, CV's) for new and improved capital equipment.

    Lead recurring conference calls with customers and issue meeting minutes as needed.

    Lead cross functional teams for investigations as required.

    Provides a leading role for the Tampa site and collaboratively works with other support groups in the MRB process to assess, recommend and implement technical resolutions to investigations, non-conformances, and OOSs/OOTs.

    Provide quotes and manages project budgets for new and existing customers for all project requests.

    Facilitate the negotiation of new and renewed supply agreements between B&L Tampa / B&L Legal / External Customer.

    Works with the broader Engineering team to recommend and implement manufacturing equipment changes when necessary.

    Works with the Validation and Quality groups to implement improvements to the product requalification subsystems.

    Reviews and approves documentation (Quality by Design, Process Validation, etc.) related to process capability of new products to assure they are developed with robust manufacturing capability.

    Ensures project compliance to all local, state and federal regulations.

    Supports department goals and Business Operational initiatives. All other duties as assigned.

    Qualifications

    BS or MS in Chemical Engineering related engineering, or physical science degree.

    Previous experience with technical transfers required.

    Strong technical skills in a cGMP environment.

    Good oral and written communication skills.

    Project management skills (PMI certification a plus), application of time management, and ability to manage budgets and supply agreements.

    Solid understanding of compounding, filling, and packaging manufacturing processes with focus on non-sterile and sterile solutions, suspensions, and ointments.  

    Be detail oriented, quality conscious, and customer service oriented.   

    Demonstrated strong leadership skills.

    Apply Here:  www.bauschhealth.com/careers  

  • February 14, 2019 9:09 PM | Anonymous member (Administrator)


    Overview

    Responsible to source, procure and inventory plan for direct materials and/or indirect materials and services necessary for the production of products in accordance with company policy, specifications and cGMP's.  Manage supplier relationships to drive improvements in quality, total cost of acquisition and support new product development.  Must be versed in subject matter for given commodities and/or services.

    Responsibilities

    Negotiate Supply and/or Service Agreements.  Issue Purchase Orders as needed for identified goods and services to support the site.  Participate and/or lead multi-disciplined teams to develop and implement sourcing strategies and tactics. Assume responsibility for the GMP, environmental health and safety procedure awareness and compliance in the respective area.

    Scope of Position:

    -           Source and Procure direct, indirect and capital materials and services to support the manufacturing plan and site operations.

    -           Implement sourcing strategies to manage critical commodities with emphasis on reducing costs, improving efficiencies and helping to assure supply chain continuity.

    -           Manage relationships with key suppliers and develop partnerships that improve overall efficiencies, quality and performance.

    -           Develop and maintain expertise for given commodities and industries inclusive of cost drivers, supply constraints and supplier base.

    -           Monitors, measure and report supplier performance in the areas of quality and delivery.

    -           Manage & monitor open orders to assure on-time deliveries in support of the production plan.

    -           Implement inventory plan and investment in specific commodities.

    -           Support Operational Excellence.

    -           This position is based primarily on API sourcing/procurement.

     

    Qualifications

    BS in Business, Chemistry, Engineering or Pharmacy

    Minimum of 5 years sourcing/procurement experience.

    Excellent verbal and written communication skills.

    Ability to prioritize multiple tasks and projects with limited direct   supervision.

    Effective organization and negotiation skills.

    Strong ability to follow up on and complete projects. Basic understanding of computers.

    API (Active Pharmaceutical Ingredient) supply base experience a plus


    Apply Here:  www.bauschhealth.com/careers 

  • February 14, 2019 9:04 PM | Anonymous member (Administrator)



    Overview

    Responsible to source, procure and inventory plan for direct materials and/or indirect materials and services necessary for the production of products in accordance with company policy, specifications and cGMP's.  Manage supplier relationships to drive improvements in quality, total cost of acquisition and support new product development.  Must be versed in subject matter for given commodities and/or services.

    Responsibilities

    Negotiate Supply and/or Service Agreements.  Issue Purchase Orders as needed for identified goods and services to support the site.  Participate and/or lead multi-disciplined teams to develop and implement sourcing strategies and tactics. Assume responsibility for the GMP, environmental health and safety procedure awareness and compliance in the respective area.

    Scope of Position:

    -           Source and Procure direct, indirect and capital materials and services to support the manufacturing plan and site operations.

    -           Implement sourcing strategies to manage critical commodities with emphasis on reducing costs, improving efficiencies and helping to assure supply chain continuity.

    -           Manage relationships with key suppliers and develop partnerships that improve overall efficiencies, quality and performance.

    -           Develop and maintain expertise for given commodities and industries inclusive of cost drivers, supply constraints and supplier base.

    -           Monitors, measure and report supplier performance in the areas of quality and delivery.

    -           Manage & monitor open orders to assure on-time deliveries in support of the production plan.

    -           Implement inventory plan and investment in specific commodities.

    -           Support Operational Excellence.

    -           This position is based primarily on API sourcing/procurement.


    Qualifications

    BS in Business, Chemistry, Engineering or Pharmacy

    Minimum of 5 years sourcing/procurement experience.

    Excellent verbal and written communication skills.

    Ability to prioritize multiple tasks and projects with limited direct   supervision.

    Effective organization and negotiation skills.

    Strong ability to follow up on and complete projects. Basic understanding of computers.

    API (Active Pharmaceutical Ingredient) supply base experience a plus

    Apply Here:  www.bauschhealth.com/careers 

  • February 14, 2019 9:01 PM | Anonymous member (Administrator)


    Overview

    Daily activities include support of utilities, facility, HVAC, and outside contracts that include: Pest Control, Security, landscaping, cafeteria services and site services; overall operation of the utility equipment. Assure that Facility/Utility related work orders, PM’s, critical system work orders are executed and completed. Oversee the passivation, preventative maintenance, shutdowns, department metrics, and training programs for department associates. Support Reliability Program.

    Responsibilities

    Support the Facility Review Board (FRB) process. 

    Leads and ensures on time completion of compliance investigations, non-conformances, deviations, CAPAs, and work orders.

    Facility and Utility departments and oversee operation, installation, and maintenance of related equipment.

    Respond to emergencies 24/7, work with the hurricane preparedness team and Coordinate Security services during facility emergencies.

    Assist validation on protocols, revalidation, review and sign-off. Assist on validation on protocols related to Utility department.

    Participating in inspections conducted by internal and external regulators and contract customers.

    Ensures compliance with EHS&S and OSHA requirements.

    Assist FM Global and EHS on liability and risk assessments.

    Support projects as needed, including document review, vendor negotiations, etc.

    Work with various state and local agencies, FDA, ETA, etc.

    Communicate with contractors on projects, contract negotiations, scheduling and compliance with company policies.

    Support activities for outside contractors for Site services, Security, landscaping, pest control, and cafeteria service to ensure they stay compliant with site and contract.

    Support the site reliability program.

    Support requests for computerized security system, as well as digital media, cameras, and intrusion systems.

    Scope of Position:

    Support activities for utility, facility, HVAC, site, security, landscaping, pest control, cafeteria services, overall operation of the utility and facility equipment. Assure that facility, utility related work orders, PM’s, critical system work orders are executed and completed.

    Qualifications

    BA Degree in Mechanical Engineering, Business or Maintenance related field. Background in Maintenance Reliability a plus.

    Logical approach to problem solving. Good organizational skills, able to work quickly and under pressure. Good verbal and written communication skills. Must be detailed and safety oriented and quality conscious.

    Project Management and leadership abilities. Computer skills with Microsoft Office a plus, and various tools. Utility computer monitoring systems, such as a BAS, EMS or BMS systems.

    5-10 years maintenance/utilities experience.  Position includes responsibility over associates to provide assistance withtroubleshooting  industrial process equipment. Pharmaceutical or food industry experience a plus.

    Apply Here:  www.bauschhealth.com/careers

  • February 14, 2019 8:58 PM | Anonymous member (Administrator)


    Overview

    To provide leadership in the Compounding Department for all personnel to ensure that quality products are manufactured to meet the production plan. Place customer service and accountability to the customer as the constant goal. Coordinate closely with other departments on operational and planning issues related to meeting the production plans and company goals. Assume responsibility for the GMP, environmental health and safety procedure awareness and compliance within the respective area.

    Responsibilities

    • Supervise, develop, provide feedback and coach employees. Complete performance reviews semi-annually.
    • Review weekly production schedule and work with the Planning department on capacity and scheduling issues. Coordinate activities to support the production schedule. Participate in process related issues using thorough technical process knowledge.
    • Perform investigations and write reports as required.
    • Review, approve, write and revise SOP's and other documentation.
    • Participate and lead in Operational Excellence projects and attend GMP training sessions as required. Train/re-train department personnel on safety, cGMPs and SOPs as needed. Work with Tech Services, R&D and Contract Manufacturing on the transfer of new products & engineering studies. Perform audits of area on scheduled basis for compliance to procedures. 
    • Asset and supply management. Generate required WOs and POs.
    • Operate department within budget guidelines. Review standards annually for necessary revisions.

    Qualifications

    BS in Science/Technical field; Chemistry, Biology or Engineering. Can be augmented with years of experience in sterile pharmaceuticals.  Demonstrated exceptional people management and leadership 

    Apply Here:  www.bauschhealth.com/careers

  • February 14, 2019 8:45 PM | Anonymous member (Administrator)


    Manage proper Inventory levels and supply flow for assigned commodities, activity requires close working relationship with procurement, shop floor planning and quality. Provide overall obsolescence analysis on monthly basis.  Provide ERP system maintenance activities. 

    Responsibilities

    1.       Inventory analysis and requisitioning to procurement for assigned commodities insuring material availability while minimizing inventory and obsolescence exposure.

    2.       Insure material receipts are processed and released in a timely fashion to support manufacturing needs.

    3.       Works closely with shop floor planning and incoming quality inspection.

    4.       Provide ERP system maintenance

    5.       Supports commodity material changes to specification and material/supplier transitions.

    6.       Responsibility for overall obsolescence planning and management on monthly basis. Forecasting potential obsolescence for future periods.

    This position will require electronic planning system knowledge to provide maintenance of these systems for inventory planning and requisitioning of materials

    This role will have planning responsibilities managing internal customer needs against supply capabilities insuring a high level of customer service while staying within inventory targeted ranges.  Will work closely with finance for management of obsolescence. 

    This position will work closing with shop floor planning and Quality expediting materials as needed.

    Qualifications

    BS in Logistics, Business or Management Sciences, Excellent communication skills throughout all levels of the organization. Detail oriented with very good organizational skills. Computerized MRP systems, MS office products with emphasis on Excel. Some knowledge of change control management.

    APICS certification preferred

    5-10 years of supply chain experience in pharmaceuticals or other process related industry.

    Apply Here:  www.bauschhealth.com/careers 

  • February 14, 2019 8:42 PM | Anonymous member (Administrator)

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

    The Manager of Aseptic Process Engineering is responsible for leadership of the engineering competency for US Pharmaceutical manufacturing and executing projects that align with the product strategy and site priorities to drive process and quality improvements, cost reduction, and ensure continuity of supply.

    • US Engineering technical manager for the Aseptic Process Engineering Team in support manufacturing process improvement, capacity scale-up, sustaining engineering and maintenance of business, and strategic programs.
    • Influential leader responsible for technical direction of the team and ownership of the aseptic process technical competency.
    • May manage project portfolios and or individual Sustaining Engineering and/or MOB projects.
    • Interfaces with multiple internal organizations and external suppliers in leading and executing projects and or strategic business initiatives.
    • Provides direction and oversight to Aseptic Process technical team.
    • Supervision of 4 full time employees and 3 contract engineers.

    Responsibilities

    • Leadership of the Aseptic Process Engineering competency and associated resources in the US Pharmaceutical plant including functional management of the group, budget, planning, and projects associated with design, development, technology transfer and production.
    • Develop and execute an engineering strategy for the US pharmaceutical plant based on industry standards and best practices ensuring regulatory compliance through the selection and implementation of the latest technology in facility design, processing equipment and methodologies.
    • Ensure that engineering knowledge, processes and best practices are leveraged across sites and drive manufacturing platform standardization where appropriate.
    • Provide leadership, guidance and support in technology transfers, new product launches, troubleshooting and problem resolution, capital project planning and executions, cost improvement and talent management.
    • Manage a portfolio of Sustaining Engineering Projects aligned with site priorities to drive process and quality improvements, reduce cost, and ensure continuity of supply.
    • Provide oversight and direction to the Pharma Maintenance of Business Portfolio Leader and support MOB projects, activities, and resource plans.

    Key Relationships: 

    • Tampa Manufacturing Site Leadership Team.
    • Tampa site Engineering Director (matrix reporting)
    • Tampa site Procurement and Finance
    • External suppliers, engineering firms, and technical consultants
    • US Engineering Leadership Team including managers and Portfolio Leaders

    Qualifications

    • BS/MS Mechanical Engineering, Chemical Engineering, Materials Science.
    • Experience with facility and equipment start-up and manufacturing in sterile cGMP pharmaceutical operations.
    • Strong background with Sterile GMP guidelines, EU standards.
    • Engineering management and technical staff development.
    • Leadership of large-scale manufacturing improvement programs/projects.
    • Familiarity with FDA regulated products.
    • Project management training or certification.
    • Strong troubleshooting and analytical capabilities with experience in DOE.
    • GMP, Six sigma, DOE, and Design for Manufacturing.
    • Strong communication and interactive skills, capable of leading and directing project teams as required.
    • Understanding Regulatory requirements for ANDA and NDA product and process changes.
    • Product and process development phase/gate methodology and manufacturing tech transfer.
    • Interfacing and communicating with site and corporate leadership.

    Apply here:   www.bauschhealth.com/careers 

  • February 14, 2019 8:38 PM | Anonymous member (Administrator)

    Overview

    Supervise the QC Chemistry Department in agreement with all regulatory requirements. Drive quality improvements of products and processes through active participation in interdepartmental areas. Supervise the QC Chemistry laboratory for in-process, finished product, customer complaint and stability samples for all products manufactured at Bausch + Lomb. Assume the responsibility for the GMP, ISO and Environmental Health and Safety procedure awareness and compliance within the respective areas. Primary back-up for QC Chemistry Lab Manager.

    Responsibilities

    1. Responsible for the supervision and development of all personnel within the QC Chemistry. 
    2. Responsible for the GMP compliance of all functions and processes of the QC Chemistry department and drive continuous improvement.
    3. Back-up role in the transfer of analytical methods and specifications from new products from R&D and CM to QC Chemistry.
    4. Provide analytical testing expertise including oversight and guidance for site engineering, R&D and CM projects and investigations.
    5. Project Management for QC Chemistry departmental projects.
    6. Review, generation and approval of analytical investigations (LIRs) and non-conformances (NCs).
    7. Responsible for the compliance of the supervised individuals to the company training policies for the QC Chemistry Department.
    8. Evaluate and upgrade lab equipment, instruments and software, capacity and efficiency.

    9. Review/approve validation and qualification protocols. Write/review/approve SOPs.

    10. Engage team to identify and implement actions to improve on-time delivery, improve right first time, and improve process efficiency.
    11. Assume the responsibility for the GMP, ISO and Environmental Health and Safety procedure awareness and compliance within the respective area.

    Qualifications

    Education: BS or MS degree in Chemistry / Biology or related scientific discipline.

    Experience: 7-10 years of laboratory work experience of which at least 3-5 years must be in the supervisory role.

    Skills: Must have demonstrated expertise and knowledge of laboratory equipment, Method Development, validation and tech transfer. 

    Other Skills: Must be able to work and solve problems independently as well as part of a team. Able to take on additional duties as required in the team environment. Should have a working knowledge of MS Word and MS Excel.

    Apply Here:  www.bauschhealth.com/careers 

  • February 14, 2019 8:36 PM | Anonymous member (Administrator)


    Overview:

    Shift coordination of Manufacturing activities. Maintain a technical understanding sufficient to provide front-line instruction for production issues.  Assume responsibility for the GMP, environmental health and safety procedure awareness, and compliance within the respective area. Support OpEx initiatives, efficiency, and continuous improvement.

    Duties:

    • Personnel Supervision. Supervise personnel in support of Compounding and Aseptic Prep activities in the pursuit of daily excellence. Assign work to manufacturing personnel. Coordinate the daily workflow with Group Leaders from other shifts.
    • Production Scheduling. Work directly with the Planning Department in development of the production schedule. Identify equipment and personnel requirements and provide solutions for constraints. Coordinate shift activities and facilitate the transfer of activities between shifts. Communicate with internal customers as frequently as required. Coordinate and escalate equipment issues with appropriate technical resources.
    • Personnel Training and Development. Oversees technical training of personnel. Mentors new personnel in behaviors and job expectations. Engages in the identification of training plan based on business needs.  Reports progress to the Team Leader. Participates in development of training plan. Ensures SOP’s are read; provides technical SOP training.
    • Compliance. Understands and enforces daily area compliance in safety/EHS procedures, GMP, and SOP/batch record adherence. Audits area compliance. Evaluates quality performance with the Team Leader and/or Manufacturing Quality Assurance.
    • Operator Substitution. Perform manufacturing compounding and/or aseptic prep operator functions when necessary.
    • Projects. Participate on project teams and R&D projects. Coordinate new product Process Validation and Cleaning Validation activities. Attend GMP training sessions as scheduled.  Represent Manager in project meetings.  Serve as leader of Operational Excellence Projects.  Support OpEx and WISE OWLS initiatives. 
    • Documentation. Review area documentation including batch records and logbooks as necessary.

    Requirements:

    5+ years of sterile pharmaceutical experience. Understanding of compounding, aseptic prep, aseptic filling or packaging including batch preparation, general CIP/SIP, sterilization and cleaning principles.  Proven experience leading people, Multi–tasking, and risk assessments.

    Special Skills:

    Excellent math skills, detail oriented, good communication skills and leadership abilities. Mechanical aptitude to understand principle of operation of various compounding and aseptic prep equipment, self-initiative. Customer service. Ability to work with multiple technical and business disciplines. Understand and apply general chemical, microbiological, and engineering/physics principles. Makes sound business decisions. Must have a general understanding of “why” activities are performed as a daily tool in making sound decisions and troubleshooting problems. Good written and verbal skills. Computer skills (email, word processing, basic spreadsheet). Makes decisions based on data when possible.   

    Apply Here:   www.bauschhealth.com/careers 

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