Senior Specialist, Engineering- Validation

Merck•Elkton, VA

1d•$117,000 - $184,200•Onsite

About The Position

This role provides leadership and technical support in areas such as Steam Sterilization, Dry Heat Depyrogenation, Steam Decontamination, Vaporized Hydrogen Peroxide Decontamination, Controlled Temperature Unit Temperature Mapping, and Warehouse Temperature Mapping Performance Qualification Validation activities. The position involves scheduling and executing PQ Validation activities, managing PQ protocol close-outs, performing technical investigations and analyses, recommending and implementing corrective actions, and reviewing procedural revisions for regulatory compliance. The role also includes data analysis, second-person review, troubleshooting PQ execution issues, writing and reviewing final reports and procedures, evaluating and implementing change controls, and aligning with Quality Management Systems (QMS). Additionally, the Senior Specialist will present as a Subject Matter Expert (SME) to regulatory inspectors, interface with Project/IPT customers, maintain and present team accomplishment metrics, manage a team of contractors and/or P1 and P2 employees, justify team headcount, author job postings, conduct interviews, evaluate candidates, assign and prioritize work, evaluate performance, provide feedback, sponsor employee growth and development through coaching, and participate in year-end assessment activities. The role also sponsors the team to achieve safety and quality compliance excellence and offers opportunities to streamline team performance and effectiveness, as well as grow as a SME and people manager.

Requirements

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

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only
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 place, introductions are position specific. Please, no phone calls or emails.

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