Senior Process Engineer (Contract - 12 Months)

The ideal candidate has a strong background in medical device manufacturing, process engineering, and process validation, preferably within GMP, ISO 9001, or ISO 13485 environments. Success in this role requires technical proficiency, a collaborative mindset, and the ability to drive projects with minimal oversight.

Responsibilities: 

• Lead projects in tech transfer, process development, process validation, and line improvements.
• Partner with global engineering teams to support the transfer of manufacturing equipment and processes to contract manufacturing sites
• Support process development activities at contract manufacturing sites.
• Define and execute process, material, and equipment qualifications
• Author and maintain engineering documentation including user requirement specification (URS), drawings, test protocols, change controls, and technical reports.
• Spearhead the review and harmonization of existing manufacturing process documentation
• Act as a Subject Matter Expert for filtration and other bioprocessing manufacturing systems.
• Identify and implement process improvements, ensuring compliance with industry standards and regulations.
• Mentor junior team members and support standardization and training of best practices.
• Apply statistical tools to support validation and process optimization efforts.
• Drive innovation in filtration systems and related support infrastructure to enhance performance and scalability.

Education and/or Work Experience:

·         Bachelor’s degree in Engineering required.

·         7–10 years of experience in medical devices or similar fields.

·         Hands-on experience with:

·         Process validation and equipment qualification

·         Tech transfer between international sites

·         Data analysis and automation

·         Filtration systems (Hollow Fiber, Flat Sheet Membranes)

·         Strong knowledge of ISO 9001, ISO 13485, or GMP manufacturing standards.

·         Proficient in SolidWorks/CAD, MS Office, and electronic file management systems.

·         Familiarity with single-use systems, sterilization techniques, and lean manufacturing principles preferred.

·         Demonstrated ability to lead cross-functional teams and manage projects in a matrixed organization.

·         High level of personal integrity, adaptability, and leadership by example.

Other requirements: 

·         Capable of independently defining and executing projects.

·         Provides technical direction and feedback to teams across disciplines.

·         Balances day-to-day plant support (20%) with project execution (80%).

·         Communicates clearly with senior leadership on project scope, risks, and progress.

·         Delegates tasks effectively and contributes to team development.

Physical Requirements:

·         Regular work in cleanroom and laboratory environments.

·         Exposure to chemicals, mechanical systems, and occasional electrical hazards.

·         May be required to lift up to 50 lbs and operate in areas with noise and vibration.