Process Equipment Engineer
Provide technical assistance to the manufacturing areas related to the manufacturing process and equipment. These areas are highly dependent on technique, detailed procedures, equipment and controls. The position requires dealing with difficult technical problems in a highly technical and regulated Biologics Plant. This position requires developing and implementing changes that will improve equipment performance and consequently product quality
To ensure continual compliance with the policies relating to Personnel, Quality, Engineering, Safety and Finance.
- Develop and modify procedures as needed to support the manufacturing operation.
- Participate in process, equipment, and facilities validations efforts and projects implementations.
- Process and equipment engineering Subject Matter Expert for a vial filling and isolator equipment from design phase to equipment handover.
- Review, and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.
- Interface with vendor to ensure that equipment/facility designs are aligned and to ensure efficient transfer of information between vendor and site
- Review vendor design documentation to ensure compliance with process and technical specifications. Lead the FAT and SAT activities ensuring the equipment is design, fabricated and tested to meet the technical requirements of the project
- Support foller equipment installation integration and co-ordinate vendor supervision as required
- Support the development of the project commissioning and validation plan. Develop commissioning plans for all process related equipment ensuring that plans meets the requirements of the company's Good Engineering Practice (GEP)
- Review all process related validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements
- Participating in design and process project conversations to ensure reliability by design is built in prior to equipment arrival.
- Leadership of manufacturing and validation activities during project life cycle.
- Support of technical transfers for future product introductions to the site.
- Assesses and owns the relationship between process requirements and unit operation equipment. Understands the impact of equipment control systems on processing performance
- Investigate process exceptions or equipment malfunction incidents affecting the process.
- Liasing with operations, quality and S&T to ensure equipment and process performance is maximized.
- To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining trouble shooting, and installing/commissioning equipment.
- Implementation of equipment/process upgrade in an environment of continuous improvement.
- Support the Production Team in ensuring that manufacturing equipment is maintained to meet the output and yield requirements.
- Adhering to all relevant policies relating to Quality & Safety.
- Ensure successful external inspections, and Division and Corporate audits.
- Supervision of external contractors.
- At least six (5) years of total combined experience in Process / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.
- At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
- Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, and sterilization operations preferable.
- Experience in new product introductions (drug product) to pharmaceutical facilities is desirable.