Specialist II - Manufacturing Sciences and Technology (MTS)

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.

What You'll Do

As a key player in our manufacturing technical team (MTS) you'll be the bridge between operations, quality, and our clients. Your mission: ensure smooth tech transfers, support GMP production, and help drive continuous improvement across aseptic and non-aseptic processes, including fill/finish and device manufacturing.

In this role, you'll:

• Serve as a technical SME during new process tech transfers

• Author and revise Batch Records, SOPs, and manufacturing documentation

• Investigate and resolve manufacturing issues to support cGMP compliance

• Participate in root cause analysis, CAPAs, and risk assessments

• Provide on-the-floor support and training to Operations staff

• Collaborate with clients to align manufacturing documents and materials

• Support implementation of new materials/processes and manage deviations

• Help promote a strong safety culture through active involvement in EHS programs

What You Bring

You're a detail-driven, solution-focused professional with:

• 3+ years in GMP manufacturing, tech ops, or regulated industry

• Experience with pharmaceutical, biotech, or medical device operations

• Knowledge of aseptic techniques, cGMP, FDA QSR, or ISO 13485

• Strong technical writing abilities (SOPs, investigations, batch records)

• Familiarity with deviation/CAPA systems and cleanroom procedures

• Proficiency in Microsoft Office and a knack for documentation accuracy

• A degree in Life Sciences, Engineering, or related field (Associate's or Bachelor's)

Bonus Points If You Have:

• Hands-on experience with GMP-scale equipment

• Background in formulation, filtration, or filling operations

• Training experience or a leadership mindset in cross-functional settings

The Environment You'll Work In

Expect a fast-paced, collaborative atmosphere where no two days are the same. You'll interface with:

• Manufacturing and project teams

• Clients and quality representatives

• Facilities, engineering, and validation departments

Work may include time in cleanrooms (aseptic and non-aseptic areas) and extended standing or light equipment handling (lifting up to 50 lbs).

Travel

Minimal (<10%) - mostly onsite and client-facing when needed.

Why PCI?

At PCI, you won't just be part of a team - you'll help build the future of contract development and manufacturing. We offer:

• Opportunities to grow in a rapidly evolving CDMO environment

• Direct impact on critical product launches

• A culture that values curiosity, collaboration, and accountability

#LI-LL1

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.