Validation Manager in Burlington, MA
AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Manager, Validation is responsible for the direct management of the site validation team and validation program, including quality oversight for validations. These include equipment, utilities, and process, cleaning and computer system validations, responsibility for review of applicable change controls and maintenance activity, and revision of the essential validation documents including the Validation Master Plan.
This individual will coordinate with functional area management to ensure equipment/staff availability to ensure timely completion of qualification activities. The Manager, Validation also ensures on-time and on-budget completion of validation/metrology activities. The Manager, Validation will work with other departments to make sure the risk assessment, IQ, OQ and PQ activities associated with new components, equipment (including laboratory testing equipment), systems, and utilities are performed according to established schedules, user requirements and needs. This position is also responsible for managing the activities of the Validation Department during facility shutdown activities and ensuring the plant is in a ready state to manufacture.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
- Key Quality oversight for all site validation activities.
- Develop, approve, schedule, oversee, and occasionally assist in the execution of Validation protocols at AMRI Burlington.
- Reviews and approves Validation Master Plans related to cleaning, facilities, packaging systems, and computer-related systems for the facility.
- Front and Back Room support during client/regulatory audits.
- Oversight of process validation, equipment cleaning (CIP/SIP) validation, and equipment validation (autoclave, vial washer, depyrogenation oven).
- Ensure the site equipment requalification program is in place and followed.
- Coordinate validation activities with department supervisors to ensure timeliness with minimal disruption to production schedules.
- Perform validation impact assessments for all equipment changes.
- Validation point of contact for validation strategies of new products and existing products.
- Perform system impact assessments to determine validation requirements for new equipment.
- Maintain site Aseptic Process Simulation (media fill) program.
- Perform regular risk assessments for Aseptic Process Simulation program and draft/review Aseptic Process Simulation reports.
- Lead and mentor a small team of validation engineers.
- Perform duties of a manager such as developing annual goals and objectives for department, developing, implementing and managing annual operating budget, approving expenditures, monitoring staffing, addressing employment issues, ensuring compliance with regulations and policies, and managing the overall functions of the Validation Department.
- Prioritize and delegate work as required to team members and provide SME oversight and guidance.
- Supervise and provide performance feedback and reviews for validation personnel.
- Participation on customer specific project teams as needed.
- Maintain Grade A/B gown qualification.
- Maintenance of AMRI Burlington Validation Master Plan and Requalification Plan.
- Responsible for continuous improvement of site validation program in collaboration with manufacturing and engineering teams.
- Bachelor’s Degree in Pharmaceutical-related science or engineering discipline
- Minimum of 7 years industry experience in a cGMP environment with direct equipment/facility validation experience
- Minimum of 3 years supervisory/management and/or project management experience in a pharmaceutical company
- Familiarity with validation tools and processes, including temperature mapping and use of Kaye Validator/Ellab equipment
- Experience with equipment specific to aseptic processing: Autoclave, Depyrogenation oven, vial filler, syringe filler, lyophilizer, vial washer
- Experience with utilities: purified water, WFI, nitrogen, compressed air, clean room validation
- Strong technical writing skills required to author validation documentation
- Ability to read, understand, interpret, and implement technical writing instructions
- Ability to work independently; demonstrated ability to interact well with other technical departments
- Previous experience in the review of validation (process, IOPQ) protocols and reports is required
- Excellent communication skills – effectively present information and respond to questions from groups of managers, clients, and customers
- Proficient in Microsoft Office and statistical analysis software
- Must have strong organizational skills and ability to prioritize, schedule and multi-task
- Experience with TrackWise/TrackWise Digital
- Excellent working knowledge of FDA cGMPs (21 CFR, 211, 820, and / or 600), Annex 1, EN 285, PDA Technical Reports, ISPE Guidance, ISO 9001, and ISO 13485 are a plus
All interested applicants must apply online.
AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.