Engineer, Pharma Validation

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Oversee the validation of facility utilities, equipment processes, and cleaning protocols for cGMP products, including pharmaceuticals, medical devices, and cosmetic items.

• Validate new equipment and revalidate existing equipment utilized in OTC/Cosmetic manufacturing as necessary.

• Conduct engineering studies to assess the feasibility of various projects.

• Develop, prepare, and implement equipment while revising test validation procedures/protocols to ensure compliance with regulatory agency validation requirements and industry standards.

• Create and execute cleaning validations.

• Manage the IQ/OQ and PQ phases of validation.

• Coordinate projects directly with vendors and service providers to ensure that all validation and installation criteria are met during protocol execution.

• Establish timelines for all projects, ensuring that deadlines and objectives are achieved.

• Regularly update management and the team on project progress.

• Collaborate proactively with division members or project teams to identify potential issues that could delay project timelines; provide recommendations to enhance completion schedules.

• Compile and analyze validation data, prepare reports, and suggest changes and improvements.

• Maintain comprehensive documentation related to the qualification and validation of assigned projects and equipment/systems.

⛳️ Requirements

• Bachelor of Science Degree in Biology, Chemistry, or Engineering.

• Minimum of 2 years of validation experience in a cGMP Device or Drug environment.

• Familiarity with validations pertaining to USP water, controlled environments, or equipment validations within a regulated setting.

• Experience with validation documentation and associated change control processes.

• Strong capability to manage multiple priorities, a self-starter attitude, excellent oral and written communication skills, and the ability to work both independently and collaboratively in an efficient manner.

🏝️ Benefits

• Health insurance.

• Life and disability insurance.

• 401(k) contributions.

• Paid time off.