Senior Specialist, Engineering- Validation

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision care

401(k)

Paid holidays

Sick days

Long-term incentive

Job summary

Merck is seeking a senior leader to drive PQ validation and qualification activities across steam sterilization, depyrogenation, and related sterilization processes in a cGMP environment. You will lead PQ execution, issue investigations, and guide cross-functional teams to compliant, sustainable solutions.

The role requires 5+ years in pharmaceutical manufacturing, strong regulatory understanding, and proven team leadership.

Qualifications

• Minimum 5 years of pharmaceutical manufacturing experience in a cGMP environment.
• Strong problem-solving skills with a hands-on field approach.
• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication.

Responsibilities

• Provide leadership and technical support in PQ validation activities (CTU/WH, Dry Heat, Steam Sterilization, VHP, mapping).
• Schedule and execute PQ validation activities and close-outs.
• Perform technical investigations and implement corrective actions to ensure sustainability.
• Review procedures for regulatory compliance and contribute to QMS alignment.
• Lead a team including contractors; hire, coach, and evaluate performance.

Skills

cGMP

Problem solving

Communication

Team leadership

Interpersonal skills

Education

Bachelor or Master in life 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 to)
• 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

Required Skills

Biochemistry, Biopharmaceutical Industry, Good Manufacturing Practices (GMP), Pharmaceutical Manufacturing, Steam Sterilization, Sterilization, Sterilization Validation, Temperature Mapping, Validation

US And Puerto Rico Residents Only

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

Requirements

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

The salary range for this role is

$117,000.00 - $184,200.00

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

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

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

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

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.

Requisition ID: R411172