Senior Specialist, Engineering- Validation

MSD•Elkton, VA

1d•Onsite

About The Position

This role provides a leadership and technical supportive role in various validation areas including 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, recommending 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 ensuring QMS evaluation and alignment. The Senior Specialist will act as a Subject Matter Expert (SME) presenting to regulatory inspectors, interface directly with customers to manage challenges, and maintain team accomplishment metrics. Additionally, this role involves managing a team of contractors and/or employees, justifying headcount, authoring job postings, conducting interviews, evaluating candidates, assigning and prioritizing work, evaluating performance, providing feedback, and sponsoring employee growth through developmental coaching and participation in year-end assessments. The role also emphasizes sponsoring the team to achieve safety and quality compliance excellence and identifying opportunities to streamline team performance and effectiveness, as well as grow as a SME and people manager.

Requirements

Minimum five (5) years of pharmaceutical manufacturing industry experience.
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 skills.
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

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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.
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.
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.
Identifying opportunities to streamline team performance and effectiveness.
Identifying opportunities to grow as both a SME and people manager.