Validation Engineer

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.

Summary

This role is responsible for designing, specifying, and maintaining control systems supporting biopharmaceutical manufacturing facilities and processes, including aseptic filling operations. This position supports end users in designing, specifying, maintaining, diagnosing, repairing, and upgrading automated control systems and instrumentation, including completion of GMP-related documentation. The Automation Engineer III will lead technical assessments and upgrade projects for automated control systems and instrumentation, including managing projects through to successful completion.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.

• Design and specify automated control systems.
• Maintain and troubleshoot automated control systems.
• Direct and perform installation of automation hardware and software.
• Program automated control systems to achieve the functional requirements.
• Oversee mechanical systems installation and participate in commissioning activities.
• Provide input for and author URS, FRS, SAT, IQ, OQ, PQ, and SOP documents.
• 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.
• Research new technologies and implement new/upgraded systems.
• Document changes to systems per change management procedures.
• Travel between facilities to support all functional areas.
• 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.
  
  

Qualifications

• Bachelor's degree in ChE, EE, IE, ME, CS, or similar discipline or equivalent experience required.
• Minimum of 5 to 8 years of relevant engineering experience including a minimum of 4 years cGMP experience.
• Well-developed understanding of automation standards (including GAMP).
• Well-developed ability with control platforms from multiple vendors (Allen Bradley, Siemens, Wonderware, iFix, Ignition, PI)
• 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–$120,150 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).

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.

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