"Alerted.org

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

+ Partner with clients, project managers, and R&D to guide products through the **technology transfer** process.

+ Provide **on-the-floor technical support** to ensure smooth manufacturing operations.

+ Lead troubleshooting efforts and develop **corrective and preventive actions** to keep production on track.

+ Design and review **batch records, SOPs, and process documentation** that meet strict cGMP and FDA/ISO requirements.

+ Analyze process data and trends to drive **continuous improvement** and operational excellence.

+ Act as a **subject matter expert (SME)** during product start-ups, inspections, and regulatory engagements.

+ Contribute to risk assessments, change controls, and investigations to ensure robust, compliant, and reliable manufacturing.

What You Bring

+ **Bachelor’s degree** in Engineering (Chemical, Life Sciences, or related) with 4+ years of industry experience in pharma, biotech, or medical devices (FDA/ISO regulated).

+ Hands-on expertise in **scale-up, tech transfer, and GMP manufacturing support** .

+ Knowledge of unit operations and equipment such as fill-finish, lyophilization, filtration, mixing, formulation, and utilities (WFI, PW, HVAC, etc.).

+ Strong communication, technical writing, and teamwork skills with the ability to influence across functions.

+ Applied knowledge of **Quality by Design, Six Sigma, and operational excellence** tools.

+ Resilience, problem-solving skills, and a **proactive mindset** to anticipate and resolve challenges.

Why Join Us?

+ Be part of a **mission-driven team** delivering therapies and devices that improve lives.

+ Work in a collaborative, client-focused environment where your expertise directly shapes outcomes.

+ Gain exposure to **cutting-edge manufacturing technologies** , including large-scale disposable systems.

+ Grow your career with opportunities for **leadership, innovation, and cross-functional collaboration** .

Additional Details

+ Must be able to lift/push/pull up to 25–50 lbs, gown for cleanroom entry, and wear required PPE.

+ This role is based in a **fast-paced, regulated cGMP environment** .

\#LI-LL1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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._

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled