Pfizer Drug Product Process Engineer, Gene Therapy Manufacturing Technical Services in Sanford, North Carolina
As a member of the Gene Therapy Manufacturing Technical Services Team located in Sanford, NC, the Drug Product Engineer is a technical process owner of assigned Drug Product unit operations and serves as a scientific and technical representative for process and equipment related projects.
During the initial phase this role will focus on supporting the Gene Therapy facility start-up, process transfers, clinical material production and process validation. Following execution of process validation the scope of work will include process performance monitoring, support for change controls and deviations as well as identification of process improvements.
Authors process descriptions, process flow diagrams and risks assessments
Designs technical and engineering studies, writes technical reports summarizing study results and generates necessary data to support change impact assessments during process transfers and investigations
Provides process related on the floor support
Supports change management and implementation for changes to the drug product manufacturing processes Owns change controls related to process changes.
Identifies potential process improvements projects. Leads implementation of process improvements projects and supports compliance driven projects that require technical support.
Supports process transfers the Sanford Gene Therapy facility.
Authors and contributes to the Drug Product process validation plans, protocols and reports.
Benchmark and monitor process performance using statistical tools
MS or BSc degree in Bioprocessing, Chemical, Biomedical or other Engineering/Sciences related discipline is required.
For MS degree- minimum of 3 years; for BSc degree minimum of 5 years of relevant experience in Aseptic Drug Product processing is required
Drug product process development and/or process transfer experience is required
Experience in authoring technical studies protocols and reports is required
An in-depth knowledge of Aseptic processing and filling unit Operations
Ability to focus on specific production processes with great attention to details
Strong leadership, organizational planning and project management skills, in addition to technical knowledge is required to work with multi-disciplinary teams
Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.
Must be self-motivated and work with minimum direction
Understanding of Quality by Design is desirable
GMP experience is preferred
Basic knowledge of Delta V is a plus and statistical tools is a plus
Remains organized & positive in ambiguous and fast-paced, rapidly changing environment
Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations
Ability to process complex information and make recommendations with incomplete data set
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Schedule is primarily day shift, but at times it will be necessary to work according to the manufacturing shift schedules (1st, 2nd or 3rd shift) to support execution of batch records when manufacturing batches during a tech transfer.
Last Date to Apply for Job: 9/29/2020
Eligible for Employee Referral Bonus
Eligible for Relocation Package
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