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Senior Biopharmaceutical Process Equipment Specialist
3 weeks ago
Job Title: Principal Project Engineer
Key Responsibilities:- Develops and specifies cGMP process equipment, piping, and controls.
- Manages small-to-mid-sized projects related to process equipment and manufacturing.
- Assists in the design review, site acceptance, and installation of equipment.
- Prepares piping and instrumentation diagrams and other related drawings.
- Develops Process Flow Diagrams for manufacturing processes.
- Sales 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.
- Implements corrective/preventative actions for existing equipment and manufacturing processes.
- Prepares engineering evaluations and test plans for change control documentation.
Maintains a clean and safe working environment by enforcing procedures, policies, and regulations. Maintains company reputation by enforcing compliance with all relevant laws, policies, and regulations.
Requirements:- Bachelor's degree in Chemical, Process or Mechanical Engineering.
- 8+ years of related experience.
- DIRECT EXPERIENCE WITH BIOPHARMACEUTICAL PROCESS EQUIPMENT IS PREFERRED.
The ideal candidate will possess excellent communication, negotiation, and stakeholder management skills, with the ability to think strategically and execute tactically in a fast-paced environment. They must be able to prioritise and re-prioritise as needed and adapt to change.