Senior Process Engineer - Aseptic Fill / Isolators (Optima H610 Required)

ABOUT COMPANY:

Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.

Senior Process Engineer - Aseptic Fill / Isolators (Optima H610 Required)

JOB SUMMARY:

Our client, a pharmaceutical CDMO, is seeking a Senior Process Engineer to drive improvements across the site, with a focus on optimizing fill line and isolator performance in a cGMP environment. This is a hands-on troubleshooting role in a fast-paced, growing manufacturing environment.

Hands-on experience with Optima fill lines is a firm requirement for this position. Applications without demonstrated Optima equipment experience will not be considered.

RESPONSIBILITIES

- Optimize fill line and isolator performance across the site
- Troubleshoot aseptic processes, particularly on EMA and Optima fill lines
- Implement process improvements in a cGMP environment
- Work with automated vial filling equipment, isolators and associated support systems
- Support filling operations and autoclave processes across suites that include formulation and filling activities
- Support development, revision and maintenance of SOPs, batch records and other process-related documentation

QUALIFICATIONS:

- Bachelor's degree in Engineering or related technical discipline
- Demonstrated hands-on experience with Optima fill lines (Optima H610 specifically preferred) - please state this explicitly in your application
- Experience with EMA fill lines
- Aseptic process troubleshooting experience
- Experience with automated vial filling equipment and isolators
- Familiarity with autoclave processes
- Reliability engineering experience is a plus
- cGMP pharmaceutical manufacturing background
- Must be legally authorized to work in the United States.
- W2 employment only

HOW TO APPLY

Please send your resume to View email address on us.fitly.work .

In your email, please state which Optima equipment you have worked on and in what capacity, along with your current location, your hourly rate expectation on W2, and your availability to start.