Quality Operations, Facilities & Validation

Merck Group • $110K — $130K *
Rahway, NJ 07065In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in science, engineering, or related technical discipline; advanced degrees preferred.
  • At least 8 years of experience in Pharmaceutical or Biotechnology industry.
  • Proven experience in Quality, Operations, or related functions at pilot/commercial scale.
  • Strong knowledge of Current Good Manufacturing Practice (cGMP).
  • Demonstrated understanding of capital project execution and facility operations.
  • Excellent interpersonal, negotiation, conflict resolution, and communication skills.

Responsibilities

  • Support cGMP quality assurance activities for clinical trial material supply facilities and equipment.
  • Provide Quality oversight throughout the capital project lifecycle from design to start-up.
  • Oversee key cGMP processes including calibration, validation, and quality risk management.
  • Collaborate with internal teams to establish strong quality oversight and communication.
  • Apply best practices to the design and maintenance of clinical-scale facilities and equipment.
  • Ensure ongoing compliance with cGMP requirements and regulatory expectations.
  • Identify operational efficiencies and implement solutions to compliance challenges.

Benefits

  • Opportunity to work on a major site expansion and clinical development capabilities.
  • Role within a supportive and collaborative Quality leadership team.
  • Engagement with cross-functional teams in a dynamic environment.
  • Potential for professional growth in a leading global pharmaceutical company.
  • Focus on innovative solutions for compliance and operational efficiency.
Full Job Description
Merck is seeking a Contractor, Quality Assurance Facilities & Validation (F&V) to join its Quality leadership team at the Rahway, New Jersey site. This role offers an exciting opportunity to serve as a subject matter expert in Quality Operations, Facilities, and Validation during a major expansion of the site's clinical development capabilities. You will work closely with cross-functional teams to provide Quality oversight across cross-modality capital projects-guiding new and existing facilities through design, qualification, start-up, and ongoing operations. The successful candidate will ensure that quality systems and controls for investigational medicinal products strictly adhere to cGMP guidelines and internal standards while balancing operational efficiency in a dynamic clinical supply environment.

Responsibilities

  • Support and execute cGMP quality assurance activities directly related to facilities, equipment, utilities, and automation assets for clinical trial material supply.
  • Provide Quality oversight for the capital project lifecycle across design phases, qualification, operational readiness, and start-up for cross-modality facilities.
  • Oversee key cGMP processes, including calibration, validation, change management, quality risk management, and root-cause quality investigations.
  • Partner with rapidly expanding internal teams to establish strong quality oversight, collaborative communication, and effective cross-organizational alignment.
  • Apply current industry best practices and benchmarks to the design, implementation, and maintenance of pilot/clinical-scale facilities and equipment.
  • Ensure ongoing compliance with regulatory expectations, cGMP requirements, and active clinical drug filings.
  • Identify operational efficiencies and implement value-added, pragmatic solutions to address complex compliance and technical challenges.
  • Sustain existing facility operations and manufacturing readiness alongside new capital project developments.

Education

  • Minimum Required: Bachelor's degree in science, engineering, or a related technical discipline.
  • Preferred: Advanced degree (Master's or Ph.D.) in science, engineering, or a related field.

Experience
Minimum Required:

  • At least 8 years of experience within the Pharmaceutical or Biotechnology industry.
  • Proven experience in Quality, Operations, or related functions at a pilot and/or commercial scale.
  • Strong working knowledge and practical application of Current Good Manufacturing Practice (cGMP).
  • Demonstrated working knowledge of capital project execution and facility operations.
  • Strong interpersonal, negotiation, conflict resolution, and written/verbal communication skills.

Preferred:

  • Direct experience in R&D, clinical trial supply material manufacturing, or clinical supply areas.
  • Foundational knowledge across validation disciplines (equipment, utilities, automation, unit operations, process development, or technology transfer).
  • Background in managing cross-functional technical teams and leading complex problem-solving initiatives.
  • Proficiency in capital project lifecycles from concept through design and start-up.

Additional Information

  • Location: Merck Site - Rahway, New Jersey.
  • Scope: Focuses on Clinical Development, R&D, and Investigational Medicinal Products (IMP) supply facilities.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

Keep Up to Date

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READ CAREERS BLOG

Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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