Process Engineer III
SK Pharmteco•King of Prussia, PA
•Onsite
About The Position
The Process Engineer III plays a critical role in supporting manufacturing and production systems for cell and gene therapy operations. This position is also deeply involved in engineering design, construction, and commissioning activities tied to capital expansion and operational projects. You’ll help develop and implement robust, scalable, and cost-effective process platforms that meet GMP standards and deliver high-quality products. This role requires strong cross-functional collaboration and technical expertise across manufacturing, process development, quality, facilities, and automation.
Requirements
- Bachelor's or Master's degree in Engineering or Life/Physical Sciences (Chemical Engineering preferred)
- 4–6+ years of experience in manufacturing process development, implementation, or optimization
- Experience with bioprocess equipment, clean utilities, GMP facilities, and automation systems
- Demonstrated ability to own medium-to-large processes or contribute to complex systems
- Comfortable providing hands-on support in cleanroom environments
- Strong understanding of cGMP regulations
- Expertise in at least one area: cell culture, fermentation, or cell processing
- Proficiency with CAD, Bluebeam, or similar tools
- Strong EHS and quality mindset
- Familiarity with Lean principles
- Excellent problem-solving and analytical skills
- Strong communication and cross-functional collaboration abilities
- Ability to manage competing priorities in a fast-paced environment
- Solid understanding of process and industrial flow
- Ability to stand for periods of time working in the laboratory.
- Ability to lift up to 15 lbs at times.
Responsibilities
- Support engineering activities related to testing, commissioning, and qualification, reporting progress to leadership
- Contribute to engineering design and installation in partnership with vendors, design firms, and contractors
- Ensure accuracy and maintenance of engineering documentation (P&IDs, mechanical drawings, automation documentation, etc.)
- Lead technical execution of mid-sized projects, including scope, scheduling, and coordination
- Review and compile Engineering Turnover Packages (EToPs)
- Conduct equipment walkdowns and ensure drawing accuracy and updates
- Collaborate cross-functionally to define requirements for system and facility modifications
- Lead troubleshooting and remediation efforts during operations and technology transfers
- Support engineering lifecycle activities with guidance from senior team members
- Partner with manufacturing teams to establish best practices for process and utility equipment
- Provide technical leadership for SOP updates, deviations, investigations, and CAPAs
- Proactively identify and resolve process and performance issues in collaboration with cross-functional teams
- Provide on-call support for process equipment and manufacturing operations as needed
- Own process equipment and single-use technologies within GMP manufacturing
- Lead troubleshooting, equipment design, and specification development
- Drive corrective and preventative maintenance activities and identify critical spare parts
- Support maintenance teams and contribute to continuous improvement initiatives
- Ensure timely closure of equipment-related CAPAs
- Author, review, and approve equipment specifications, engineering procedures, and validation protocols
- Support updates to manufacturing documentation (SOPs, batch records, etc.)
- Maintain and update engineering drawings, including redlines and revisions
- Ensure compliance with cGMP standards and industry best practices
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
