Job description

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. Essential Duties and Responsibilities: Maintain and troubleshoot manufacturing and utility equipment. Update manufacturing systems. Provide input and author URS, FDS, SAT, I/O/PQ, and SOP documents. Document changes to systems per change management procedures. Research new technologies and make recommendations. Advanced knowledge of plant and equipment reliability. Travel between facilities to support all functional areas. Maintain and troubleshoot automated control systems related to process equipment as well as the Building Management System (Siemens: Insight and Desigo). Evaluate existing systems for continuous improvement. Provide in-depth technical review of all documents and complete GMP documentation including change controls, data integrity assessments, deviations and CAPAs, and the closing of audit observations. Act as a technical and professional mentor for junior colleagues. Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture. Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures Qualifications: Bachelor s degree in ChE, EE, IE, ME, CS, or similar discipline or equivalent experience required. Minimum of 7-10 years of relevant engineering experience including a minimum of 4 years cGMP experience. Understanding of plant and equipment reliability preferred. Well-developed understanding of automation standards (including GAMP). Well-developed understanding of control platforms from multiple vendors (Allen Bradley, Siemens, Wonderware, iFix, PI). Extremely strong working knowledge of GMP, aseptic techniques, and laboratory compliance. Highly proficient in Microsoft Office applications. Excellent attention to detail, critical thinking, and communication skills. Able to work autonomously, drive results, and collaborate in a cross-functional environment. The base salary hiring range for this position is $106,800 - $133,500 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-AK2 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.

Requirements

Must-haves

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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.
Maintain and troubleshoot manufacturing and utility equipment.
Update manufacturing systems.
Provide input and author URS, FDS, SAT, I/O/PQ, and SOP documents.
Document changes to systems per change management procedures.
Research new technologies and make recommendations.
Advanced knowledge of plant and equipment reliability.
Travel between facilities to support all functional areas.
Maintain and troubleshoot automated control systems related to process equipment as well as the Building Management System (Siemens: Insight and Desigo).
Evaluate existing systems for continuous improvement.
Provide in-depth technical review of all documents and complete GMP documentation including change controls, data integrity assessments, deviations and CAPAs, and the closing of audit observations.
Act as a technical and professional mentor for junior colleagues.
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture.
Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures
Bachelor s degree in ChE, EE, IE, ME, CS, or similar discipline or equivalent experience required.
Minimum of 7-10 years of relevant engineering experience including a minimum of 4 years cGMP experience.
Well-developed understanding of automation standards (including GAMP).
Well-developed understanding of control platforms from multiple vendors (Allen Bradley, Siemens, Wonderware, iFix, PI).
Extremely strong working knowledge of GMP, aseptic techniques, and laboratory compliance.
Highly proficient in Microsoft Office applications.

Nice-to-haves

Understanding of plant and equipment reliability preferred.

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: workday
Effort: long

Benefits

Benefits detected in the listing.

Health Insurance

Dental

Vision

401(K)

Paid Time Off