Job DescriptionWe invite you to become a part of our journey as the Technical Operations Associate Director, Validation Lead. This role offers you the chance to contribute to the site's development and ensure successful GMP manufacturing.
In this position the Technical Operations Associate Director will play a pivotal role in ensuring the site establishes and maintains all aspects of validation across drug substance and drug product. In partnership with quality, technical operations, engineering and maintenance and the site manufacturing team will provide comprehensive equipment and system validation leadership for the site supporting the continued build, commissioning and qualification. This position will continue within the role from design through operation of the facility.
Bring energy, knowledge, innovation to carry out the following:- Build, develop and lead the site validation organization, establishing capability, governance, standards and succession plans to support startup and long-term commercial operations
- Partner with the global validation CoE and drive continuous improvements across the site and network to ensure the site maintains the highest level of regulatory compliance.
- Lead and engage with the engineering design firms in detailed design on all aspects of drug substance and drug product manufacturing.
- Clearly own and hold team accountable for
- Validation Master Plan
- Continued Process Verification (CPV)
- Cleaning Validation
- Computer System Validation / CSA strategy (if applicable)
- Lifecycle management of validated systems
- Inspection readiness
- Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT).
- Develop project appropriate guidance documents as necessary.
- Support equipment qualification deliverables including equipment Commissioning & Qualification, IOQ, etc.
- Creation, review and revision of technical documents including manufacturing batch records, SOPs and technical memos.
- Establish and maintain the standards to validate and maintain the validated state of all equipment across DS & DP.
- Oversee the Engineering Batches, Process Performance Qualifications and commercial manufacturing including authoring relevant filing sections.
- Provide technical leadership for new product introductions (Tech Transfer).
- Serve as the site validation SME during health authority inspections, partner audits and regulatory submissions.
What skills you will need:To excel in this role, you will need:
- Bachelor's degree in engineering, science or related discipline.
- 10+ years of increasing responsibility in validation, engineering or technical operations within a cGMP biologics, sterile manufacturing or pharmaceutical environment.
- Start-up experience in a large-scale commercial drug substance and/or drug product facility highly desirable
- Experience supporting highly potent compounds, containment systems, isolator technologies and antibody-drug conjugate manufacturing strongly preferred.
- Demonstrated ability to lead and operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
- Previous experience in validation of building systems (WFI, autoclaves, etc.) and production systems (chromatography skids, isolators, filtration skids, etc.) is desired.
- Experience with aseptic process simulation (APS)/media fills, aseptic qualification strategy, isolator qualification, visual inspection validation, container closure integrity, lyophilization and cleaning validation including VHP experience is highly desired.
- Previous experience of manufacturing and technical support of shakedown batches engineering batches, developmental batches and PPQ runs.
- Previous experience with CQV activities will be advantageous.
- Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
- Experience in a risk-based approach to manufacturing through use of tools such as FMEA.
- Ability to adapt to changing priorities as project demands change.
- Demonstrated skills in planning, communication (oral and written) and technical writing.
Required Skills: API Manufacturing, API Manufacturing, Change Control Systems, Chemical Process Development, Commercial Operations Management, Computer System Validation (CSV), Cross-Cultural Awareness, Cross-Functional Teamwork, Equipment Qualification, FMECA, Manufacturing Documentation, Manufacturing Process Controls, Manufacturing Processes, Manufacturing Process Validation, Manufacturing Strategies, Matrix Management, Operational Qualification, People Leadership, Pharmaceutical Manufacturing, Process Optimization, Process Verification, Product Approvals, Regulatory Compliance, Regulatory Inspections, Regulatory Requirements {+ 9 more}
Preferred Skills: Current Employees apply HERE
Current Contingent Workers apply HERE
Employee Status: Regular
Relocation:Domestic
VISA Sponsorship:No
Travel Requirements:10%
Flexible Work Arrangements:Not Applicable
Shift:Not Indicated
Valid Driving License:No
Hazardous Material(s):high potent compounds
Job Posting End Date:09/21/2026
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