Senior Specialist, Engineering- Validation

MSD Malaysia; Elkton (VA); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision and other insured benefits

Retirement plan (401(k))

Paid holidays

Vacation

Sick days

Job summary

Merck in the United States seeks a senior QA/validation leader to guide PQ qualification and related regulatory activities in a fast-paced pharma environment.

The role requires five+ years in pharma manufacturing, strong problem-solving, and proven team leadership. You will coordinate cross-functional teams, review validation protocols, and ensure compliance with QMS and regulatory expectations across multiple sites.

Qualifications

• Minimum five (5) years of pharmaceutical manufacturing industry experience.
• Working in a cGMP environment.
• Strong problem-solving with hands-on field analysis.
• Excellent technical, organizational, interpersonal, and communication skills.
• Ability to evaluate issues from safety, compliance, maintenance, automation, equipment, process, and people perspectives.
• Experience acting as a team leader.
• Knowledge of CTU/WH qualification/validation, Dry Heat Depyrogenation, Steam Sterilization/Sanitization, and VHP Decontamination validation.

Responsibilities

• Provide leadership and technical support in PQ validation activities.
• Schedule and execute PQ validation activities and close-outs.
• Perform technical investigations and analyses and drive corrective actions.
• Review procedures for regulatory compliance and write final reports.
• Engage in change control evaluation and QMS alignment.
• Present SME findings to regulatory inspectors and interface with project teams.
• Manage contractors and internal staff, justify headcount, and coach for growth.
• Participate in year-end assessments and sponsor team development.

Skills

Leadership

Problem-solving

Regulatory compliance

Verbal and written communication

Interpersonal collaboration

Team leadership

Education

Bachelor or Master degree in biology/biochemistry/biomedical engineering/chemical engineering/biological sciences

Job description

Job Description Primary Responsibilities

• Providing a leadership and technical supportive role in the areas of Steam Sterilization, Dry Heat Depyrogenation, Steam Decontamination, Vaporized Hydrogen Peroxide Decontamination, Controlled Temperature Unit Temperature Mapping and Warehouse Temperature Mapping Performance Qualification Validation activities (but not limited to)
• Scheduling and executing PQ Validation activities
• Scheduling and managing PQ protocol close-outs
• Performing technical investigations and analyses
• Driving to and recommending corrective actions and seeing them through to successful/sustainable implementation
• Reviewing procedural revisions to be compliant with regulatory expectations
• Data analysis and Second Person Review
• Troubleshooting activities associated with all aspects of PQ execution
• Final report and procedure writing and review
• Change control evaluation / implementation
• QMS evaluation / alignment
• SME presentation to regulatory inspectors
• Directly interfacing with Project / IPT customers to manage pinches / challenges
• Maintain team accomplishment metrics and present as needed
• Manage of team of Contractors and / or P1 and P2 employees (including but not limited too)
• Justifying appropriate team headcount
• Authoring job postings / conducting interviews / evaluating candidates as needed
• Assigning / Assisting with prioritization of work responsibilities
• Evaluating performance and providing regular feedback
• Sponsoring employee growth and developmental opportunities through routine 1:1 developmental coaching
• Participating in Year End assessment activities as applicable
• Sponsoring the team to achieve Safety and Quality compliance excellence
• Multiple opportunities will be provided to stream-line team performance and effectiveness
• Multiple opportunities will be provided to grow as both a SME and people manager

Education Minimum Requirement

Bachelor or Master degree in, biology, biochemistry, biochemical engineering, biological systems engineering, biomedical engineering, chemical engineering, computer science, integrated science or related life science or engineering discipline

Required Experience and Skills

• Minimum five (5) years of pharmaceutical manufacturing industry
• Working in a cGMP environment
• Effective problem-solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field
• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication
• Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it
• Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications
• Willingness to work as a contributing member of a dynamic team of individuals
• Experience acting as a team leader
• Knowledge and/or experience in CTU/WH qualification / validation
• Dry Heat Depyrogenation qualification / validation
• Steam Sterilization / Sanitization qualification / validation
• VHP Decontamination qualification / validation

Eligibility and Equal Opportunity

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Please click here if you need an accommodation during the application or hiring process.

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 and Incentives

The salary range for this role is $117,000.00 - $184,200.00.

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.

An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits.

• medical
• dental
• vision healthcare and 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.

Location and Work 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.

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: No

Travel Required: No

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date

Job Posting End Date: 08/25/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About the Company

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.