Project Engineer Contractor
Industry : Pharmaceutical
Designs, specifies and commissions new and renovated biopharmaceutical process equipment.
Provides engineering support and problem solving for existing equipment and manufacturing processes.
Role Duties and Responsibilities:
Duties and responsibilities include, but are not limited to, the following:
- Managing and coordinating contractors ranging from civil, mechanical, electrical, and automation.
- Strong knowledge in safe working procedures.
- Managing all aspects of project financial control.
- Ability to report project status and align with aggressive timelines.
- Designs and specifies cGMP process equipment, piping, and controls.
- Scope and update functional Design Specifications (FDS) for automation updates on process equipment.
- Manages small-to-mid sized projects related to process equipment and manufacturing. Types of equipment exposed to are as follows: WFI, CIP, Bioreactors, Centrifuges, Chromatography, Media Prep, Buffer Prep and UFDF.
- Assists in the design review, site acceptance and installation of equipment.
- Updates piping and instrumentation diagrams (P&ID) and other related drawings.
- Updates Process Flow Diagrams for manufacturing processes.
- Supports QA Validation department by preparation of design documents and assists in protocol execution.
- Assists in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
- Identifies & implements corrective/preventative actions (CAPAs) for existing qualified GMP equipment and manufacturing processes through site change control process.
- Identifies & implements process improvements for manufacturing processes and utilities.
- Prepares engineering evaluations and test plans for and executes change control documentation.
- Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
- Assists with tech transfer activities, such as process scale up and New Product Introductions (NPIs).
Education and Experience:
- Requires BS/BEng in Chemical, Process or Mechanical engineering with 3 – 5 years related experience.
- Direct experience with biopharmaceutical process equipment is preferred. May substitute relevant experience for education.
- GMP and GDP experience would be desirable.
Contract Duration: 12 month contract with hybrid working.