Cindavi
Base pay range
$75,000.00/yr - $90,000.00/yr
Job Description We are seeking a Validation Engineer to support validation activities within a commercial manufacturing facility. This role is responsible for developing, executing, and maintaining validation protocols to ensure systems, processes, and products meet regulatory, quality, and internal requirements. The Validation Engineer will work closely with cross‑functional teams to support Therapeutics manufacturing operations and continuous improvement initiatives in a cGMP environment.
Responsibilities
Develop, execute, and maintain validation protocols and reports aligned with regulatory requirements and project objectives
Lead and contribute to risk assessments related to validation activities
Ensure validation work is performed in accordance with internal validation policies, procedures, and the Master Validation Plan
Coordinate and execute validation activities including IQ, OQ, PQ, requalification, and revalidation of critical systems and utilities
Assist in preparing protocols for process qualification, cleaning validation, equipment commissioning and qualification, and CSV documentation
Review and analyze analytical and physical data generated during validation activities
Author validation and qualification final reports supported by objective evidence and obtain required approvals
Partner with Development, Manufacturing, Engineering, and Quality teams to generate risk management deliverables such as PHAs, SIAs, FMEs, and risk management reports
Work closely with R&D, Quality, Engineering, Manufacturing, and IT teams to align validation activities with project milestones
Qualifications
Bachelor’s degree in a scientific discipline or equivalent relevant experience
2 to 5+ years of validation experience within pharmaceutical or medical device manufacturing
Strong understanding of validation principles, methodologies, and regulatory requirements
Hands‑on experience drafting and executing IQ, OQ, and PQ documentation
Experience working in cGMP‑regulated environments
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Job Description We are seeking a Validation Engineer to support validation activities within a commercial manufacturing facility. This role is responsible for developing, executing, and maintaining validation protocols to ensure systems, processes, and products meet regulatory, quality, and internal requirements. The Validation Engineer will work closely with cross‑functional teams to support Therapeutics manufacturing operations and continuous improvement initiatives in a cGMP environment.
Responsibilities
Develop, execute, and maintain validation protocols and reports aligned with regulatory requirements and project objectives
Lead and contribute to risk assessments related to validation activities
Ensure validation work is performed in accordance with internal validation policies, procedures, and the Master Validation Plan
Coordinate and execute validation activities including IQ, OQ, PQ, requalification, and revalidation of critical systems and utilities
Assist in preparing protocols for process qualification, cleaning validation, equipment commissioning and qualification, and CSV documentation
Review and analyze analytical and physical data generated during validation activities
Author validation and qualification final reports supported by objective evidence and obtain required approvals
Partner with Development, Manufacturing, Engineering, and Quality teams to generate risk management deliverables such as PHAs, SIAs, FMEs, and risk management reports
Work closely with R&D, Quality, Engineering, Manufacturing, and IT teams to align validation activities with project milestones
Qualifications
Bachelor’s degree in a scientific discipline or equivalent relevant experience
2 to 5+ years of validation experience within pharmaceutical or medical device manufacturing
Strong understanding of validation principles, methodologies, and regulatory requirements
Hands‑on experience drafting and executing IQ, OQ, and PQ documentation
Experience working in cGMP‑regulated environments
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