Associate Director, Engineering
Merck
August 31, 2026
On-site
Wilmington, DE
Operations
Technical Operations Associate Director, Validation Lead
Responsibilities
- Build, develop, and lead the site validation organization (governance, standards, succession plans) for startup and long-term commercial operations.
- Partner with the global validation CoE to drive continuous improvements and maintain regulatory compliance.
- Lead engagement with engineering design firms for drug substance and drug product manufacturing.
- Own/lead validation areas: Validation Master Plan, CPV, Cleaning Validation, CSV/CSA strategy (if applicable), lifecycle management of validated systems, inspection readiness, FAT/SAT participation.
- Develop guidance documents; support equipment qualification (Commissioning & Qualification, IOQ, etc.).
- Create/review/revise technical documents (batch records, SOPs, technical memos).
- Oversee Engineering Batches, Process Performance Qualifications, and commercial manufacturing; author filing sections.
- Provide Tech Transfer leadership for new product introductions.
- Serve as site validation SME for health authority inspections, partner audits, and regulatory submissions.
Qualifications
- Bachelor’s degree in engineering, science, or related discipline.
- 10+ years increasing responsibility in validation, engineering, or technical operations in cGMP biologics/sterile/pharmaceutical.
- Startup experience in large-scale commercial DS/DP highly desirable.
- Strongly preferred: experience with highly potent compounds, containment/isolator technologies, and ADC manufacturing.
- Demonstrated matrix leadership executing FAT, SAT, IQ/OQ, engineering batches.
- Desired: validation of WFI/autoclaves and production systems (e.g., chromatography skids, isolators, filtration skids); APS/media fills, aseptic qualification, isolator qualification, visual inspection validation, container closure integrity, lyophilization, cleaning validation (VHP).
- Advantageous: CQV; data-driven RCA/continuous improvement (Six Sigma); risk-based tools (FMEA); technical writing/planning/communication.
Benefits (if applicable)
- Eligible for annual bonus and long-term incentive (if applicable) and a comprehensive benefits package (medical/dental/vision, 401(k), paid holidays/vacation, etc.).
Application
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.
Responsibilities
- Build, develop, and lead the site validation organization (governance, standards, succession plans) for startup and long-term commercial operations.
- Partner with the global validation CoE to drive continuous improvements and maintain regulatory compliance.
- Lead engagement with engineering design firms for drug substance and drug product manufacturing.
- Own/lead validation areas: Validation Master Plan, CPV, Cleaning Validation, CSV/CSA strategy (if applicable), lifecycle management of validated systems, inspection readiness, FAT/SAT participation.
- Develop guidance documents; support equipment qualification (Commissioning & Qualification, IOQ, etc.).
- Create/review/revise technical documents (batch records, SOPs, technical memos).
- Oversee Engineering Batches, Process Performance Qualifications, and commercial manufacturing; author filing sections.
- Provide Tech Transfer leadership for new product introductions.
- Serve as site validation SME for health authority inspections, partner audits, and regulatory submissions.
Qualifications
- Bachelor’s degree in engineering, science, or related discipline.
- 10+ years increasing responsibility in validation, engineering, or technical operations in cGMP biologics/sterile/pharmaceutical.
- Startup experience in large-scale commercial DS/DP highly desirable.
- Strongly preferred: experience with highly potent compounds, containment/isolator technologies, and ADC manufacturing.
- Demonstrated matrix leadership executing FAT, SAT, IQ/OQ, engineering batches.
- Desired: validation of WFI/autoclaves and production systems (e.g., chromatography skids, isolators, filtration skids); APS/media fills, aseptic qualification, isolator qualification, visual inspection validation, container closure integrity, lyophilization, cleaning validation (VHP).
- Advantageous: CQV; data-driven RCA/continuous improvement (Six Sigma); risk-based tools (FMEA); technical writing/planning/communication.
Benefits (if applicable)
- Eligible for annual bonus and long-term incentive (if applicable) and a comprehensive benefits package (medical/dental/vision, 401(k), paid holidays/vacation, etc.).
Application
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.