Associate Director, Engineering

MSD Malaysia; Wilmington (DE); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck in Wilmington, DE is seeking a Technical Operations Associate Director, Validation Lead to drive site validation for drug substance and drug product as part of a new ADC manufacturing facility.

The role requires leading validation programs, coordinating with quality, engineering and maintenance, and ensuring regulatory readiness across CPV, equipment qualification and CQV activities.

Qualifications

• Bachelor’s degree in engineering, science or related discipline.
• 10+ years in validation, engineering or technical operations in biopharma.
• Start-up experience in large-scale commercial drug substance and/or drug product facility desirable.
• Experience supporting highly potent compounds, containment systems, isolator technologies and ADC manufacturing.
• Demonstrated ability to lead and operate within a matrix team on FAT, SAT, IQ/OQ and engineering batches.
• Experience in validation of building systems (WFI, autoclaves) and production systems (chromatography skids, isolators).
• Experience with APS/media fills, isolator qualification, visual inspection validation, container closure integrity, lyophilization and cleaning validation including VHP.

Responsibilities

• Build and lead the site validation organization with governance and standards.
• Drive regulatory compliance improvements across the site and network.
• Lead engineering design interactions for drug substance and drug product manufacturing.
• Own Validation Master Plan and site qualification activities.
• Support CPV, Cleaning Validation and CSV strategy.
• Oversee equipment qualification and IOQ/IQ activities.
• Contribute to filing sections and lifecycle management of validated systems.
• Provide technical leadership for Tech Transfer and new product introductions.
• Act as site validation SME during inspections and audits.

Skills

Leadership

Regulatory compliance

Validation

Process validation

GMP

Technical writing

Education

Bachelor's degree in engineering, science or related discipline

Tools

CQV

Six Sigma

FMEA

Job description

Job Description

Job Description Welcome to the Future of Precision Oncology – Join Us in Wilmington, DE! We’re thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware—a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. ADCs represent one of the most exciting frontiers in biopharmaceuticals today. By combining the targeting power of monoclonal antibodies with the potency of cytotoxic drugs, ADCs deliver cancer-killing agents directly to tumor cells, minimizing damage to healthy tissue. This precision has revolutionized treatment for hematologic malignancies and is rapidly expanding into other cancers. The global ADC market is booming, projected to surpass $16 billion in 2025 and grow steadily through 2035. Innovations in linker technology, payload design, and AI-driven antibody optimization are accelerating breakthroughs and expanding therapeutic possibilities. Our Wilmington facility is designed to meet the growing demand for high-potency manufacturing, ensure supply chain resilience, and support the next wave of ADC launches. Importantly, this site will support both drug substance conjugation and drug product. This is more than a job - it’s a chance to be part of the next wave of cancer care. Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute to life-changing therapies for patients around the world. Together, we’ll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact. Join us in Wilmington and help shape the future of cancer treatment—one molecule at a time.

Role Overview

We 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.

Responsibilities

• 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.

Skills & Requirements

• 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 a 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.

#ADC 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

US and Puerto Rico Residents Only:

Inclusion & Equal Opportunity

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

Salary & Benefits

The salary range for this role is $142,400.00 - $224,100.00

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

• medical
• dental
• vision healthcare
• other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Employment Details

• 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

Application Deadline

The application deadline for this position is stated on this posting.

Location Requirements

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance