CQV Engineer Lead - Pharma Equipment Validation

Verista, Inc.; Bloomington (IN); In loco; USD 79.000 - 123.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health Insurance

Dental Insurance

Life Insurance

Retirement Plan

Paid Time Off

Descrizione del lavoro

Verista, Inc. is seeking engineers in Bloomington, IN to support commissioning, qualification, and validation of manufacturing equipment for life sciences clients.

You will work with project teams to install, test, and certify equipment, ensuring cGMP compliance and thorough documentation. Ideal candidates have 5+ years of CQV experience and a strong background in FAT/SAT, IQ/OQ/PQ, and P&ID interpretation.

Competenze

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline preferred, or equivalent industry experience.
• 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.
• Strong understanding of manufacturing equipment and equipment systems, including how equipment is designed, installed, operated, tested, and maintained.
• Ability to read and interpret engineering drawings, equipment specifications, P&IDs, and technical documentation.
• Ability to author clear and technically accurate engineering and CQV documentation.
• Strong troubleshooting and problem-solving skills with the ability to identify and resolve equipment-related issues.
• Understanding of cGMP requirements and Good Documentation Practices.
• Strong communication, organizational, and project coordination skills.

Mansioni

• Provide hands-on support in the field during equipment installation, startup, testing, and qualification.
• Support FAT, SAT, commissioning, and qualification activities as required.
• Author, review, and revise CQV and engineering documentation, including URS, commissioning protocols, IQ/OQ/PQ protocols and reports.
• Identify equipment and system issues and drive resolution with project teams and vendors.
• Coordinate with equipment vendors, engineering, manufacturing, automation, and Quality teams.

Conoscenze

CQV lifecycle

FAT / SAT

IQ/OQ/PQ protocols

Engineering drawings

Documentation drafting

Troubleshooting

Communication skills

Project coordination

Formazione

Bachelor’s degree in Engineering, Life Sciences, or related

5+ years pharma CQV/engineering experience

Descrizione del lavoro

Verista, Inc. is seeking engineers in Bloomington, IN to support commissioning, qualification, and validation of manufacturing equipment for life sciences clients.

You will work with project teams to install, test, and certify equipment, ensuring cGMP compliance and thorough documentation. Ideal candidates have 5+ years of CQV experience and a strong background in FAT/SAT, IQ/OQ/PQ, and P&ID interpretation.