Validation Specialist

Valspec; Makkah Region; On-site; SAR 262,000 - 338,000; Full time

Job summary

A leading company in equipment validation is seeking a GMP Equipment Validation Specialist to support CQV activities for various equipment. The candidate should have a Bachelor's degree and 3+ years of experience in a GMP environment. The role involves leading validation projects and ensuring compliance with regulatory standards. The company offers competitive benefits, including premium medical coverage and 401(k) matching.

Benefits

Premium medical coverage

401(k) with company match

Strong ownership culture

Competitive benefits package

Qualifications

• 3+ years of experience in CQV within a GMP-regulated environment.
• Strong understanding of validation lifecycle and regulatory expectations.
• Experience with automated systems and controls integration is a plus.

Responsibilities

• Lead and execute CQV activities for GMP equipment.
• Develop and review validation documentation including URS, DQ, IQ, OQ, and PQ.
• Troubleshoot and resolve equipment and process issues during commissioning and qualification.

Skills

GMP validation

Risk assessment

Communication skills

Organizational skills

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

Job Title

GMP Equipment Validation Specialist – CQV

Position Overview

We are seeking a highly motivated and detail-oriented GMP Equipment Validation Specialist to support Commissioning, Qualification, and Validation (CQV) activities for a range of manufacturing and utility equipment at a client site in Swiftwater, PA. This role is ideal for someone who thrives in a dynamic environment, can work independently, and is confident interfacing directly with client teams.

Key Responsibilities

Lead and execute CQV activities for GMP equipment including:

• Autoclaves
• CIP/SIP systems
• Bioreactors
• Incubators
• Washers
• Controlled temperature units
• HVAC systems
• WFI systems
• Utility systems (compressed air, nitrogen, etc.)

Develop and review validation documentation including URS, DQ, IQ, OQ, and PQ protocols and reports.

Perform risk assessments and impact analyses to support validation strategy.

Coordinate with client engineering, automation, and quality teams to ensure alignment on project goals and timelines.

Troubleshoot and resolve equipment and process issues during commissioning and qualification phases.

Maintain compliance with cGMP, FDA, and other applicable regulatory requirements.

Provide timely updates and communicate effectively with client stakeholders.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years of experience in CQV within a GMP-regulated environment.
• Strong understanding of validation lifecycle and regulatory expectations.
• Experience with automated systems and controls integration is a plus.
• Excellent organizational and communication skills.
• Ability to work independently and manage multiple priorities.

Why Join Valspec?

At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:

• Premium medical coverage
• 401(k) with company match
• And more — all designed to support your growth, well-being, and future.

Legal and Equal Opportunity

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Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.
Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.