Senior Validation Engineer

This Jobot Job is hosted by: Christian Aviles
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Salary: $110,000 - $125,000 per year

A bit about us:

We're a growing contract development and manufacturing organization that partners with biopharmaceutical companies from early-stage process development through commercial manufacturing.

Why join us?

This is an opportunity to join a growing organization where your work will have a direct impact on the company's commercial success. You'll have the freedom to build relationships, develop new business, and grow strategic accounts without getting lost in a large corporate structure. You'll also work closely with experienced technical and operational teams while helping biopharmaceutical customers move important therapies from development through commercial manufacturing.

Job Details

Senior Validation Engineer

Industry: Pharmaceutical Manufacturing
Employment Type: Full-Time
Reports To: Validation Leadership

A Bit About Us

Our client is a growing pharmaceutical manufacturing organization operating in a highly regulated environment. They're looking for an experienced validation professional who enjoys hands-on work, solving technical problems and ensuring manufacturing systems remain safe, reliable and compliant.

Position Summary

We are seeking a Senior Validation Engineer to design, execute and maintain validation programs within a GMP-regulated manufacturing environment. This position will validate equipment, utilities, laboratory systems and computerized systems while ensuring all applicable quality and regulatory requirements are met.

This is a hands-on role requiring direct experience performing validation activities-not solely reviewing documentation.

Responsibilities
Develop and execute IQ, OQ and PQ protocols.
Establish validation standards and document test results.
Prepare equipment for testing and write final validation reports.
Revalidate steam and dry-heat sterilizers using Kaye validation systems.
Develop new sterilization cycles when needed.
Validate autoclaves, lyophilizers and other manufacturing equipment.
Review manufacturing and laboratory equipment periodically.
Maintain calibration records and calibrate equipment as needed.
Implement Validation Master Plans for equipment and processes.
Validate utilities such as water systems and air-handling units.
Support change controls, deviations and quality documentation.
Create and update standard operating procedures.
Conduct risk-based assessments and validate Part 11 systems.
Participate in internal and regulatory audits.
Issue maintenance work orders and recommend equipment or process improvements.
Qualifications
Bachelor's degree in engineering, life sciences or a related field.
Hands-on validation experience within a GMP-regulated pharmaceutical, biotechnology or similar manufacturing environment.
Experience developing and executing IQ/OQ/PQ protocols.
Strong technical writing and documentation skills.
Working knowledge of Microsoft Word, Excel and PowerPoint.
Ability to collaborate effectively with Engineering, Manufacturing and Quality teams.
Preferred Experience
Autoclave and steam-sterilization validation.
Lyophilizer or lyophilization equipment.
Kaye validation systems.
Grade A, ISO 5 or Class 100 cleanrooms.
Aseptic or sterile pharmaceutical manufacturing.
Equipment calibration and utility-system validation.
FDA 21 CFR Part 11 requirements.
Physical and Environmental Requirements

The position may require frequent movement, extended periods of sitting or standing, use of computers and manufacturing equipment, wearing required PPE and occasional exposure to noise, chemicals or varying temperatures. Some bending, reaching, lifting and nonstandard working hours may be required.

Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.

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