Senior Specialist, Engineering- Validation

Merck & Co.; Elkton (VA); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical benefits

Job summary

Merck & Co. in the United States—Virginia Elkton site—seeks a leadership role overseeing PQ/validation in Steam Sterilization, Dry Heat Depyrogenation, Steam Decontamination, VHP Decontamination, and Temperature Mapping, with compliance to regulatory expectations.

The role includes scheduling PQ activities, change control, QMS alignment, and mentoring contractors and P1/P2 staff, plus growth to SME and people manager.

Qualifications

• Minimum five (5) years of pharmaceutical manufacturing experience in a cGMP environment.
• Strong problem-solving, leadership, and cross-functional collaboration capabilities.
• Experience acting as a team leader and in regulatory-facing roles.

Responsibilities

• Provide leadership and technical support in PQ validation activities for CTU/WH, Dry Heat, Steam Sterilization, and VHP decontamination.
• Schedule and manage PQ protocols, close-outs, investigations, and change control.
• Review procedures for regulatory compliance and perform data analysis with second person review.
• Mentor contractors and staff; develop performance and growth through coaching and feedback.
• Interfacing with customers and regulators; drive safety and quality compliance.

Skills

Biochemistry

Biopharmaceutical Industry

GMP

Pharmaceutical Manufacturing

Steam Sterilization

Sterilization

Sterilization Validation

Temperature Mapping

Validation

Education

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

Job description

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:

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:

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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.

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The salary range for this role is

$117,000.00 - $184,200.00

This 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.

• medical