What are the responsibilities and job description for the Principal Process Engineer (Sterile Fill Finish) position at PCI Pharma Services?
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We're looking for a hands-on, highly skilled Principal Process Engineer to lead complex engineering projects from concept to completion. In this role, you'll be working with state of the art isolated sterile fill finish equipment and supporting plant systems, optimizing and fine tuning equipment performance, and ensure our facilities and utilities run at world-class standards. This is an opportunity to apply your deep technical expertise, mentor other engineers, and play a key role in our capital projects, all while working in a fast-paced, highly regulated environment.
What You'll DoLead & Deliver Projects - Oversee the design, procurement, installation, and start-up of new plant utilities, equipment, and systems.
Engineer for Excellence - Optimize performance of packaging equipment and manufacturing systems for maximum efficiency and reliability.
Own the Process - From URS and risk assessments to vendor management and factory/site acceptance testing, you'll ensure every step meets technical and regulatory requirements.
Be the Go-To Expert - Troubleshoot complex systems (water pretreatment, high-purity water, clean steam, compressed air, nitrogen, HVAC, freeze dryers, fill-finish lines) and keep production running smoothly.
Mentor & Influence - Share your expertise, guide junior engineers, and champion continuous improvement initiatives.
Collaborate Across Teams - Work closely with Manufacturing, Quality, Facilities, Validation, and EHS to align engineering solutions with business needs.
Education - BS or MS in Chemical, Mechanical, or related Engineering discipline.
Experience - 12 years in engineering/facilities/utilities (preferably biotech, medical device, or pharmaceutical).
Technical Expertise - GMP/FDA regulations, aseptic processes, capital project execution, and advanced utilities systems. Experience working with one of the following: Isolators, Sterile fill finish, lyophilizers.
Tools & Skills - MS Office Suite, MS Project, AutoCAD/SolidWorks; CMMS, PLC knowledge a plus.
Mindset - Detail-oriented, organized, hands-on, and able to thrive in a fast-paced CMO environment.
Leadership - Proven ability to manage people, projects, budgets, and timelines with strong communication and negotiation skills.
Work on mission-critical projects that directly support life-saving products.
Lead with impact - influence strategy, mentor engineers, and shape facility capabilities for years to come.
Be part of a collaborative, safety-focused culture where engineering is a driver of innovation, not just maintenance.
Competitive compensation, benefits, and opportunities for career growth.
Able to lift/move up to 50 lbs and gown for cleanroom access.
Occasional travel (<10%) between facilities.
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Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.