Process Engineer I
The Process Engineer I position is an entry level position that requires the capacity and willingness to learn multiple biological manufacturing platforms for impacting global health initiatives. The individual will have the desire to grow in both personal and professional areas of competence. The Process Engineer I is responsible for the assessment and technology transfer of new manufacturing processes that support clinical and commercial manufacturing. This position will work cross-functionally to define the manufacturing processes for current Good Manufacturing Practice (cGMP) production.
Responsibilities and Duties:
- Supports the introduction of new manufacturing processes and methods to facilitate clinical and commercial manufacturing of biological drug substances and products.
- Coordinates the information transfer and gap assessment of new processes and method transfers.
- Drafts technology transfer protocols according to developed manufacturing processes.
- May draft cGMP documentation according to Technology Transfer Protocols, such as master batch records, material specifications, sampling plans, etc.
- Supports protocol development and respective reports related to late-stage product development activities.
- Collects and trends manufacturing process data for use in late-stage process risk assessments and to support continuous performance verification.
- Coordinates and supports cGMP changes using quality management records such as change controls, corrective and preventative actions (CAPAs), etc.
- Supports the documentation of events and deviations during cGMP manufacturing production.
- Supports the assessment of unit operation bill of materials (BOMs) and drafting of BOMs for production planning and manufacturing.
- Supports the material forecasting of process materials and equipment.
- Supports facility fit assessments of manufacturing processes in production suites.
- May support other tasks as determined by management.
Basic Qualifications
- Bachelor of Science in engineering typically in chemical engineering, material science and engineering, or industrial engineering;
- Requires 0 – 2 years of experience in any applicable regulated industry;
- Strong leadership, relationship management, and organizational planning;
- Ability and willingness to learn and adapt skillsets for various areas of MS&T;
- Ability to perform well under aggressive timelines with maintenance of high-quality output while under pressure;
- Knowledge of cGMP compliance around bioprocess drug substance manufacturing.