Senior Specialist, Engineering- Validation

Job DescriptionPrimary 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 activitiesScheduling and managing PQ protocol close-outsPerforming technical investigations and analysesDriving to and recommending corrective actions and seeing them through to successful/sustainable implementationReviewing procedural revisions to be compliant with regulatory expectationsData analysis and Second Person ReviewTroubleshooting activities associated with all aspects of PQ executionFinal report and procedure writing and reviewChange control evaluation / implementationQMS evaluation / alignmentSME presentation to regulatory inspectorsDirectly interfacing with Project / IPT customers to manage pinches / challengesMaintain team accomplishment metrics and present as neededManage of team of Contractors and / or P1 and P2 employees (including but not limited too)Justifying appropriate team headcountAuthoring job postings / conducting interviews / evaluating candidates as neededAssigning / Assisting with prioritization of work responsibilitiesEvaluating performance and providing regular feedbackSponsoring employee growth and developmental opportunities through routine 1:1 developmental coachingParticipating in Year End assessment activities as applicableSponsoring the team to achieve Safety and Quality compliance excellenceMultiple opportunities will be provided to stream-line team performance and effectivenessMultiple opportunities will be provided to grow as both a SME and people managerEducation 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 disciplineRequired Experience and SkillsMinimum five (5) years of pharmaceutical manufacturing industryWorking in a cGMP environmentEffective 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 communicationAbility to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve itEnthusiasm, confidence and initiative-taking ability needed for continuous learning and its applicationsWillingness to work as a contributing member of a dynamic team of individualsExperience acting as a team leaderKnowledge and/or experience in: CTU/WH qualification / validation; Dry Heat Depyrogenation qualification / validation; Steam Sterilization / Sanitization qualification / validation; VHP Decontamination qualification / validationRequired Skills: Biochemistry, Biopharmaceutical Industry, Good Manufacturing Practices (GMP), Pharmaceutical Manufacturing, Steam Sterilization, Sterilization, Sterilization Validation, Temperature Mapping, ValidationPreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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 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 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 .You can apply for this role through (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 OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation:DomesticVISA Sponsorship:NoTravel Requirements:No Travel RequiredFlexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob 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. SummaryLocation: USA - Virginia - ElktonType: Full time