Validation Engineer

Essential Duties and Responsibilities

• 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.

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 automation 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.

Pay

The base salary hiring range for this position is $93,360 - $107,280 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.

Benefits

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).