Our client is seeking a Drug Product Process Engineer for a 2-3+ year assignment.
On site % by Quarter:
1Q – 2023 – 25%
2Q- 2023 – 50%
3Q – 2023 – 75%
4Q- 2023 – 100%
1Q – 2024 – 100%
2Q- 2024- 100%
3Q – 2024 – 100%
4Q- 2024 – 100%
Client is looking for someone with a filling and lyophilization equipment background for the buildout project. Managing Factory Acceptance Testing, development and implementation of all filling equipment SOPs, maintenance procedures and risk assessments. Client is looking for a background with new facility expansion or buildout in their past experience.
The Drug Product Process Engineer is responsible for the design, installation, testing and qualification of all biopharmaceutical formulation, filling, lyophilization and finishing equipment for the new drug product manufacturing site in the USA. The Drug Product Process Engineer will interact with end users, engineers, equipment vendors and system integrators to deliver all aspects of filling and finishing for the new facility.
- Responsible for matching the filling and lyophilization manufacturing operations to the project product portfolio requirements.
- Preliminary and detailed design of filling and lyophilization operations including process flows and review of shop drawings.
- Selection or filling and lyophilization equipment.
- Coordinate with other disciplines including architects, structural, mechanical, I&C, electrical engineers, and client personnel to ensure the design requirements are met.
- Work directly with facility planners to layout the Formulation, fill, finish process needs including space, adjacencies, and flows.
- Right-sizing filling and lyophilization automation.
- Coordinate and assemble filling and lyophilization components, materials, and specifications.
- Manage the overall filling and lyophilization equipment budget.
- Manage the factory acceptance testing (FAT) process including assembly of test components, approving test designs, and completion of test protocols.
- Manage the on-site commissioning and qualification of filling and lyophilization operations.
- Coordinating formulation, filling, lyophilization, capping and inspection information from design thru training of operations personnel. Coordinate with other disciplines including architects, structural, mechanical, I&C, electrical engineers, and client personnel to ensure the design requirements are met.
- Ensure accuracy and completeness of turnover packages including all process equipment drawings and manuals, testing records, tools, spare parts and consumables.
- Responsible for operation of all filling equipment from commissioning until final handover to the Operations team.
- Develop and implement all filling equipment SOPs, maintenance procedures and risk assessments.
- Assist the installation, commissioning, start-up and qualification of process and clean utilities systems.
- Complete qualification activities for all clean utilities, and support operations to qualify processing systems.
The Drug Product Process Engineer will interact with internal and external project team members, and with other Client manufacturing sites to ensure a smooth transition of formulation, fill, finish operations. The successful candidate will also need demonstrate the ability to work closely with engineering, OEMs, integrators, validation specialists and end users. Collaboration and partnership are essential to succeed in this role.
Education and Experience:
- Over 10 years of experience delivering pharmaceutical formulation, filling, lyophilization, capping and inspection projects associated with large scale biologics & vaccine manufacturing facilities.
- Extensive experience managing all project stages from user requirement specification (URS) development, design specification review, materials management optimization, layout reviews, vendor technical reviews, factory inspection, factory acceptance testing (FAT), site acceptance testing (SAT), qualification and final handover to end-user.
- Experience with all major filling, freeze-drying, capping, conveying, and formulation equipment manufactures and long-time professional relationships at original equipment manufacturers (OEMs).
- Experience in precision filling and aseptic filling.
- Experience with primary filling materials and vendors of those materials.
- Experience in filling and lyophilization automation and data collection.
- Bachelor of Science in engineering.
Technical Skills Requirements:
- Strong proactive leadership, interpersonal, teamwork and problem solving skills.
- Excellent written and verbal communication skills.
- Demonstrated project management skills.
- Able to analyze complex problems independently, deal with differences, and make appropriate decisions timely.
GA: Drug Product Process Engineer (232289)