Position Summary & Role (general description of the role, e.g., expectations, key milestones, impact)
The Process Engineer II will have 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 II 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.
Job Responsibilities (core responsibilities; include people management if applicable)
- 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.
- May draft cGMP documentation according to Technology Transfer Protocols, such as master batch records, material specifications, sampling plans, etc.
- 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 process equipment on-boarding such as the drafting of user requirement specifications and drafting process equipment operational and maintenance standard operating procedures (SOPs).
- Support the coordination of process equipment movement and readiness check based on manufacturing forecasting.
- 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.
- Adheres to Resilience Standard of Behavior Agreement and Expectations.
Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)
- Bachelor of Science in engineering typically in chemical engineering, material science and engineering, industrial engineering, or mechanical engineering.
- Draft of GMP documentation:
- Risk Assessments, FMEAs.
- URS/URSD, CSIA, SLIA, CCA – Equipment on boarding
- Tech Transfer Protocols
- Bill of Materials and Bill of Equipment (platform)
- Facility Fit Reports
- Campaign Summary Reports
- Experience in one of the following:
- Cell Culture (fermentation, adherent, suspension)
- TFF (UFDF)
- Viral Inactivation
- Viral Filtration
- POD Filtration
- Aseptic Technique
- Support MFG GMP Campaigns on the floor
- Collaborates with Process Development on Process Confirmation Execution
- Evaluates Material Substitutes as required
- Demonstrated process understanding of at least one manufacturing platform supporting drug substance production and purification using adherent or suspension cell culture; or successful experience in the implementation of a drug product manufacturing process.
- 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.
- Knowledge of regulatory compliance in pharmaceutical development
Physical Requirements: (rows or statements that are not required to perform the duties of the position)
This job requires the employee to perform the following physical activities:
- Repetitive motion
This job requires the employee to work in the following conditions:
- Typical Office Environment
This job requires the employee to perform the following type of physical work:
- Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
This job requires the following visual acuity requirements:
- Preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.