Senior Specialist, Engineering- Validation

MSD • Elkton, VA

2d • $117,000 - $184,200 • Onsite

About The Position

This role provides 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. The position involves scheduling and executing PQ Validation activities, managing PQ protocol close-outs, performing technical investigations and analyses, and recommending corrective actions. It also includes reviewing procedural revisions for regulatory compliance, conducting data analysis and Second Person Review, troubleshooting PQ execution issues, and writing/reviewing final reports and procedures. The role also encompasses change control evaluation/implementation, QMS evaluation/alignment, presenting as a Subject Matter Expert (SME) to regulatory inspectors, and interfacing with Project/IPT customers. Additionally, the Senior Specialist will maintain team accomplishment metrics, manage a team of Contractors and/or P1 and P2 employees, justify headcount, author job postings, conduct interviews, 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 grow as both 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

• Preferred Skills:

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

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior