VALIDATION ENGINEER I

PCI Pharma Services • Bedford, NH

5d

About The Position

Under the guidance and mentorship of senior level Validation Engineers and management, the Validation Engineer I will execute an array of well-defined validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple PCI facilities. The Validation Engineer assists internal project teams and external validation firms on validation/qualification initiatives to ensures project schedules are met. Complies with requirements of the Safety Program, including PCI Health and Safety mandates and OSHA requirements. In carrying out duties, contributes and promotes a positive and equitable working environment emphasizing the PCI Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

Requirements

• Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments. Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
• Associate/Bachelor’s degree in Engineering or related scientific discipline with 1-3 years of Pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, or Engineering.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities.
• Possess functional knowledge of commissioning, qualification validation, practices, including applicable regulations.
• Strong technical writing, verbal communication and presentation skills.
• Proficiency in Microsoft Office including Word, Excel, Power Point, Project
• Organized individual who is accustomed to working in a result oriented-focused, dynamic CMO environment.
• Professional and collaborative team player must have strong interpersonal skills.
• Honesty, integrity, respect and courtesy with all colleagues.
• Self-motivated and able to meet goals following the input and guidance of management as well as from more experienced Validation Engineering team members.

Responsibilities

• Perform administrative activities such as data entry into Validation scheduling tools, scan validation documents, and file validation documents
• Execute Test Protocols, including identification and resolution of non-conformances/deviations.
• Assist with test protocols for installation, operation, performance of equipment, and IQ/OQ/PQ.
• Under the direction of senior level validation engineers and manager execute validation related activities IQ/OQ/PQ for (Facilities, equipment, utilities, processes, and materials)
• Work closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to schedule validation deliverables.
• Coordinate and work on Validation deviations and participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).
• Collaborate and propose corrective actions to validation manager to implement the required changes.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree