Eblex Group
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This range is provided by Eblex Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $90,000.00/yr - $130,000.00/yr
Direct message the job poster from Eblex Group
International Life Sciences and Technology Recruitment About the Role
We are supporting a client of ours with their search for a motivated and detail-oriented
Validation Engineer
to join their growing team.
The successful candidate will be responsible for planning, executing, and maintaining validation activities in a GMP-regulated biopharmaceutical or pharmaceutical manufacturing environment. This role ensures that all equipment, utilities, facilities, and processes comply with FDA, EMA, and other applicable regulatory standards.
Key Responsibilities
Plan, develop, and execute validation activities for GMP systems, equipment, utilities, and processes (IQ/OQ/PQ).
Support qualification and validation of manufacturing systems including autoclaves, cleanrooms, HVAC, WFI, purified water, and clean steam systems.
Develop and maintain validation protocols, reports, risk assessments, and master plans in compliance with company SOPs and industry standards.
Participate in equipment and process commissioning and troubleshooting as part of validation activities.
Ensure validation documentation meets regulatory and company quality requirements.
Collaborate with Engineering, Quality Assurance, and Manufacturing teams to support project execution and ongoing GMP compliance.
Participate in deviation investigations, CAPA implementation, and change control assessments.
Support regulatory inspections and client audits related to validation systems.
Maintain awareness of current regulatory expectations, industry trends, and validation best practices.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
3–7 years of experience in GMP validation within the pharmaceutical, biotech, or medical device industry.
Hands-on experience executing IQ/OQ/PQ and maintaining validation documentation.
Strong knowledge of FDA, EMA, ICH, and USP regulatory guidelines and industry standards (ISPE, ASTM E2500).
Experience with utilities and process equipment validation (e.g., autoclaves, bioreactors, CIP/SIP systems, HVAC, purified water).
Validation Engineer | Biotechnology | Biotech | Life Sciences | Quality Assurance | IQOQPQ | Pharmaceuticals | FDA | GMP | Manufacturing | Equipment Validation
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Quality Assurance
Industries: Biotechnology Research and Pharmaceutical Manufacturing
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Chemical or Mechanical Engineering Internship Assistant Professor, Chemical Engineering - 500001 Intern/Co-op – Midstream Natural Gas and NGL Services Mechanical/Chemical/Petroleum/Civil/Electrical Engineering (Summer 2026) Intern/Co-op – Midstream Natural Gas and NGL Services Mechanical/Chemical/Petroleum/Civil/Electrical Engineering (Summer 2026) Medtronic - Associate Mapping Specialist - Central, application via RippleMatch Technology Leadership Associate - 2026 Leadership Development Program Ph.D. Chemical and Biomolecular Engineering Tutor Chemical and Biomolecular Engineering Tutor Chemical and Biomolecular Engineering Tutor Chemical and Biomolecular Engineering Tutor We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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This range is provided by Eblex Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $90,000.00/yr - $130,000.00/yr
Direct message the job poster from Eblex Group
International Life Sciences and Technology Recruitment About the Role
We are supporting a client of ours with their search for a motivated and detail-oriented
Validation Engineer
to join their growing team.
The successful candidate will be responsible for planning, executing, and maintaining validation activities in a GMP-regulated biopharmaceutical or pharmaceutical manufacturing environment. This role ensures that all equipment, utilities, facilities, and processes comply with FDA, EMA, and other applicable regulatory standards.
Key Responsibilities
Plan, develop, and execute validation activities for GMP systems, equipment, utilities, and processes (IQ/OQ/PQ).
Support qualification and validation of manufacturing systems including autoclaves, cleanrooms, HVAC, WFI, purified water, and clean steam systems.
Develop and maintain validation protocols, reports, risk assessments, and master plans in compliance with company SOPs and industry standards.
Participate in equipment and process commissioning and troubleshooting as part of validation activities.
Ensure validation documentation meets regulatory and company quality requirements.
Collaborate with Engineering, Quality Assurance, and Manufacturing teams to support project execution and ongoing GMP compliance.
Participate in deviation investigations, CAPA implementation, and change control assessments.
Support regulatory inspections and client audits related to validation systems.
Maintain awareness of current regulatory expectations, industry trends, and validation best practices.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
3–7 years of experience in GMP validation within the pharmaceutical, biotech, or medical device industry.
Hands-on experience executing IQ/OQ/PQ and maintaining validation documentation.
Strong knowledge of FDA, EMA, ICH, and USP regulatory guidelines and industry standards (ISPE, ASTM E2500).
Experience with utilities and process equipment validation (e.g., autoclaves, bioreactors, CIP/SIP systems, HVAC, purified water).
Validation Engineer | Biotechnology | Biotech | Life Sciences | Quality Assurance | IQOQPQ | Pharmaceuticals | FDA | GMP | Manufacturing | Equipment Validation
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Quality Assurance
Industries: Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Eblex Group by 2x
Get notified about new Validation Engineer jobs in
Ohio, United States .
Chemical or Mechanical Engineering Internship Assistant Professor, Chemical Engineering - 500001 Intern/Co-op – Midstream Natural Gas and NGL Services Mechanical/Chemical/Petroleum/Civil/Electrical Engineering (Summer 2026) Intern/Co-op – Midstream Natural Gas and NGL Services Mechanical/Chemical/Petroleum/Civil/Electrical Engineering (Summer 2026) Medtronic - Associate Mapping Specialist - Central, application via RippleMatch Technology Leadership Associate - 2026 Leadership Development Program Ph.D. Chemical and Biomolecular Engineering Tutor Chemical and Biomolecular Engineering Tutor Chemical and Biomolecular Engineering Tutor Chemical and Biomolecular Engineering Tutor We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr