Validation Engineer - Entegee

Job Summary:
The Validation Engineer supports cleanroom and analytical instrument qualifications and computerized system validations within a pharmaceutical manufacturing framework following cGMP standards.

Job Requirements:

• Experience with URS, vendor qualifications, IQ/OQ documentation, and PQ protocols for analytical instrument and computerized systems.
• Engineering or Science degree with a minimum of 5 years of validation engineering experience.
• Experience with chillers and freezers highly preferred.
• Familiarity with pharmaceutical standards and regulations (FDA, EU, ISO, ISPE, etc.).
• Additional experience in validation of analytical equipment, associated software, and temperature units.
• Proficient in using Good Documentation Practices (GDP) during document creation and review.
• Ability to thrive in a fast-paced environment and manage shifting priorities.

Preferred Skills:

• Ability to create and manage validation schedules and coordinate execution with various teams.
• Proficient in generating protocols, reviewing documents, and generating reports in a GMP atmosphere.
• Knowledge of Quality Risk Management principles.
• Proficient in managing changes to ensure continued qualification of systems, equipment, and facilities.

Job Responsibilities:

• Support the qualification of cleanrooms, analytical instruments, and computerized systems.
• Collaborate with Engineering, Maintenance, Manufacturing, QA, IT, and other departments during protocol execution.
• Develop and review URS, vendor qualifications, IQ/OQ documentation, and PQ protocols for analytical instrument/computerized systems.
• Analyze engineering study results to formulate conclusions and recommendations.
• Author and review design documents for analytical instruments/computerized systems.
• Assess impacts of proposed changes on validated states of instruments and systems.
• Execute qualification protocols for equipment, instrumentation, and facilities.
• Generate closing reports for executed protocols and manage validation schedules.
• Navigate a Management of Change system to assess and manage changes impacting qualification status.
• Focus on Controlled Temperature Unit qualifications, with secondary priority on Analytical Instrument qualifications.
• Conduct annual validation reviews to ensure compliance and identify areas needing attention.

Pay Details: $54.00 to $72.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.