Plant Engineer III

Qualifications:

• BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
• A minimum of 5 plus years’ experience in engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device or pharmaceutical industry.
• Strong understanding of technical project management, Good Engineering Practices, reliability, and Lean Principles
• GMP and non-GMP change control, maintaining regulatory compliance
• Experience with aseptic liquid filling of vials, CIP/SIP and Clean Room, lyophilization, aseptic filling of vials, and aseptic processes, including refrigerated and frozen capabilities a Plus.
• Experience with Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA control system.
• Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus.
• Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes.
• Strong organization, interpersonal, oral and good written communication skills.
• Proficiency with standard software applications, including MS Word, MS Excel, MS Project, MS Power Point,
• Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices.
• Effectively support internal and external relationships, key stakeholders and vendors.
• Excellent understanding of team and group dynamics.
• Demonstrated agility to working in a fast-paced CMO environment.
• Excellent technical writing abilities
• #LI-CW1
• 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.