Senior Specialist, Engineering- Validation

MSD Malaysia; Virginia, Northern (IL, KY); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Benefits package

Job summary

Merck & Co., Inc. seeks a Senior Specialist, Engineering- Validation in US Virginia to lead validation activities in steam sterilization, dry heat, VHP decontamination, and temperature mapping.

You will manage PQ scheduling, protocol close-outs, investigations, and reporting, while coordinating with QA, manufacturing, and regulatory teams to ensure compliance and continuous improvement.

Qualifications

• Minimum five (5) years of pharmaceutical manufacturing experience in a cGMP environment.
• Experience leading validation activities and cross-functional collaboration with QA, manufacturing, and regulatory.
• Strong problem-solving, communication, and data analysis skills.

Responsibilities

• Provide leadership and technical support for PQ validation activities including CTU/WH, Dry Heat, Steam Sterilization, and VHP decontamination.
• Schedule, execute, and close PQ validation protocols and reports.
• Drive corrective actions and ensure sustainable implementation in a regulated environment.
• Prepare and review validation documentation, change controls and QMS alignment.
• Interface with customers and internal teams to manage project priorities and resource needs.

Skills

Biochemistry

Biopharmaceutical Industry

GMP

Pharmaceutical Manufacturing

Steam Sterilization

Sterilization

Temperature Mapping

Validation

cGMP

Education

Bachelor’s or Master degree in life sciences/engineering

Job description

Senior Specialist, Engineering- ValidationSkip to main content*This site uses cookies to provide you with an optimal user experience. The cookies include Strictly Necessary and Functional cookies to ensure the site operates as intended (language preference, time zone and workload balance). These cookies are first party cookies, end with the session and are exempted from consent. In addition, this site also uses a Google Analytics Cookie to measure and improve the performance of our site. All information these cookies collect is aggregated and therefore anonymous. By clicking on the ‘Accept Cookies’ button, you are accepting this Performance cookie. You may use this site if you click on the ‘Reject Cookies’ button. To revoke your consent of the Performance cookie, clear your cookies within your browser settings.*#Senior Specialist, Engineering- Validation page is loaded## Senior Specialist, Engineering- ValidationApplyremote type: Not Applicablelocations: USA - Virginia - Elktontime type: Full timeposted on: Posted Todaytime left to apply: End Date: August 25, 2026 (14 days left to apply)job requisition id: R411172**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**Required Skills:**Biochemistry, Biopharmaceutical Industry, Good Manufacturing Practices (GMP), Pharmaceutical Manufacturing, Steam Sterilization, Sterilization, Sterilization Validation, Temperature Mapping, Validation**Preferred Skills:**Current Employees apply HERECurrent Contingent Workers apply HERE**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. 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 RightsEEOC GINA SupplementWe 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 ActsThe salary range for this role is$117,000.00 - $184,200.00This 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.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.You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.**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**Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.**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.**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.