Position Summary:
Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized products. Lead the validation team in the establishment and maintenance of validated systems. Coordinate technology transfer activities in support of commercialization. Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development and validation of new products, as needed.
Job Responsibilities:
- Plan, perform and coordinate validation projects to ensure timely completion
- Responsible for drafting and providing technical guidance for the validation program, Policies and SOPs and other master documents
- Support Engineering and Manufacturing in the development of critical process parameters and provide technical leadership for deviation investigations
- Analyze data to provide recommendations for improvements in the manufacturing process and equipment
- Assess new and existing processes (including Equipment IOPQ, Process, etc.) against cGMP and requirements for validation
- Develop and implement strategies for equipment IQ/OQ/PQ, process validation, computer system validation and calibration
- Perform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter experts
- Oversee development and execution of validation protocols and review objective evidence for inclusion in validation reports
- Assist with the technical assessment and resolution of deviances and variances that occur during production or validation
- Work with Quality, Manufacturing, Regulatory, and subject matter experts to prepare for FDA and other agency audits
- Ensure site/system validation program meets FDA, ISO and EU requirements
- Collaborate with peers and stakeholders to in QA and Manufacturing to identify opportunities for process improvement
- Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites
- Provide updates to Senior Management on site validation status activities
- Provide validation training to staff on validation protocols and standard operating procedures
- Support investigations and implementation of CAPAs, as needed
- Perform any other duties assigned
Required Skills:
- Must have exceptionally strong communication, interpersonal and project management skills
- Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment
- Ability to lead a team of validation associates to prioritize and manage multiple projects across several product lines
- Ability to manage consultants and set expectations for the quality and timeliness of their deliverables
Education and Experience Requirements:
- Bachelors, Masters, or Ph.D. in Biochemistry, Biology, or related science field
- Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 in a manufacturing setting
- Demonstrated application of FMEA, Risk Analysis, Validation principles, guidelines, and industry best practice
- Demonstrated history of team management and effecting cross-functional change with strong analytical problem solving and interpersonal skills
- Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non-technical audience
- At least 8 years' experience in the biotech/pharmaceutical industry in validation, quality management, process controls, and continuous improvement in an FDA-regulated environment
- A minimum of 4 years' experience with aseptic and terminally sterilized products
EOE, including disability/vets.
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