Synerfac Technical Staffing
Overview
The Senior Specialist, Validation will lead and execute validation activities across sterile and aseptic manufacturing environments, supporting facilities, utilities, equipment, laboratory systems, and manufacturing processes. This individual will ensure that all validation activities meet current industry standards, regulatory requirements (FDA, EMA, Annex 1), and internal quality expectations. The ideal candidate will demonstrate strong technical expertise, project leadership, and collaboration within cross-functional teams. Responsibilities
Develop and execute validation protocols (IQ/OQ/PQ) for clean utilities, autoclaves, isolators, sterilizers (VHP & steam), laboratory instruments, fillers, and controlled temperature units. Conduct risk assessments to determine critical process parameters and validation requirements. Manage and lead validation projects, including new equipment installation, capital expansions, and re-qualification of legacy systems. Analyze data, write validation reports, and ensure timely approval and closure of validation documentation. Review and approve protocols, SOPs, change controls, CAPAs, and technical reports. Act as SME during audits (regulatory, client, internal) and support the preparation and defense of validation-related topics. Collaborate with Quality Assurance, Engineering, Operations, and external vendors to ensure compliant and efficient validation execution. Ensure alignment with GAMP5, ISPE Baseline Guides, FDA Process Validation Guidance, and EU Annex 1. Provide mentorship and technical guidance to junior validation engineers and specialists. Stay updated on industry trends and regulatory expectations; propose improvements to the validation program accordingly. May lead or support investigations and root cause analysis related to deviations or non-conformances on validated systems. Qualifications
Required Qualifications Bachelor's degree in Engineering, Life Sciences, or related STEM discipline. Minimum 5 years of validation experience in the pharmaceutical or biopharmaceutical industry, specifically in sterile/aseptic manufacturing. Experience with validation of: • Sterilization processes (Steam & VHP) • Sterile filtration & aseptic process validation (APV/PPQ) • ISO 5 isolators, cleanrooms, utilities In-depth knowledge of cGMP regulations, Annex 1, FDA Guidance, and validation of lifecycle requirements. Excellent communication skills to articulate technical information clearly in a GMP environment. Proficient in Microsoft Office (Word, Excel, Outlook); experience with validation tools/software preferred. Ability to manage multiple projects simultaneously and meet tight deadlines in a fast-paced environment. Experience with Cleaning Validation and Computer System Validation (CSV). Salary Range: $40.00 - $45.00
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The Senior Specialist, Validation will lead and execute validation activities across sterile and aseptic manufacturing environments, supporting facilities, utilities, equipment, laboratory systems, and manufacturing processes. This individual will ensure that all validation activities meet current industry standards, regulatory requirements (FDA, EMA, Annex 1), and internal quality expectations. The ideal candidate will demonstrate strong technical expertise, project leadership, and collaboration within cross-functional teams. Responsibilities
Develop and execute validation protocols (IQ/OQ/PQ) for clean utilities, autoclaves, isolators, sterilizers (VHP & steam), laboratory instruments, fillers, and controlled temperature units. Conduct risk assessments to determine critical process parameters and validation requirements. Manage and lead validation projects, including new equipment installation, capital expansions, and re-qualification of legacy systems. Analyze data, write validation reports, and ensure timely approval and closure of validation documentation. Review and approve protocols, SOPs, change controls, CAPAs, and technical reports. Act as SME during audits (regulatory, client, internal) and support the preparation and defense of validation-related topics. Collaborate with Quality Assurance, Engineering, Operations, and external vendors to ensure compliant and efficient validation execution. Ensure alignment with GAMP5, ISPE Baseline Guides, FDA Process Validation Guidance, and EU Annex 1. Provide mentorship and technical guidance to junior validation engineers and specialists. Stay updated on industry trends and regulatory expectations; propose improvements to the validation program accordingly. May lead or support investigations and root cause analysis related to deviations or non-conformances on validated systems. Qualifications
Required Qualifications Bachelor's degree in Engineering, Life Sciences, or related STEM discipline. Minimum 5 years of validation experience in the pharmaceutical or biopharmaceutical industry, specifically in sterile/aseptic manufacturing. Experience with validation of: • Sterilization processes (Steam & VHP) • Sterile filtration & aseptic process validation (APV/PPQ) • ISO 5 isolators, cleanrooms, utilities In-depth knowledge of cGMP regulations, Annex 1, FDA Guidance, and validation of lifecycle requirements. Excellent communication skills to articulate technical information clearly in a GMP environment. Proficient in Microsoft Office (Word, Excel, Outlook); experience with validation tools/software preferred. Ability to manage multiple projects simultaneously and meet tight deadlines in a fast-paced environment. Experience with Cleaning Validation and Computer System Validation (CSV). Salary Range: $40.00 - $45.00
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