GMP Engineering Specialist

Merck Group • $64K — $99K *
St. Louis, MO 63129In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Associate Degree in Chemistry, Biology, Controls Engineering, Mechanical Engineering, or related field.
  • Vocational degree or certification in industrial maintenance, electronics, or similar with 1+ years experience in GMP role.
  • High School Diploma or GED with 3+ years experience in GMP manufacturing.
  • Bachelor's Degree in Engineering or Science preferred.
  • 2+ years experience in cGMP Quality, Engineering, or Manufacturing preferred.

Responsibilities

  • Coordinate documentation and operational tasks for validation, maintenance, and engineering.
  • Author technical reports and quality records, including maintenance plans and standard operating procedures.
  • Manage Change Controls, Deviations, and CAPAs with cross-functional teams.
  • Conduct investigations and root cause analyses for equipment/facility issues.
  • Maintain CMMS by updating records and managing work orders in compliance with cGMP.
  • Support equipment commissioning and validation activities, including routine maintenance shutdowns.
  • Track alarm responses and prepare operational reports.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO).
  • Retirement contributions.
  • Potential for sales or performance-based bonuses.
Full Job Description
Your Role:

In this role you will be responsible for assisting Engineering, Maintenance, and Validation with quality support as it relates to CMMS administration, change control, equipment non-conformances, equipment deviations, routine maintenance plan updates, technical document creation, and alarm response tracking and reporting. This position is located at the 3300 South Second Street facility.

Responsibilities include but are not limited to:
  • Coordinate validation, maintenance, and engineering documentation and operational tasks.
  • Author technical reports, quality records, maintenance plans, and Facility/Equipment Operating Procedures.
  • Manage Change Controls, Deviations, and CAPAs in the QMS across cross-functional teams (Engineering, QA, Manufacturing, Validation).
  • Manage equipment/facility investigations, troubleshooting, root cause analysis, and risk assessments.
  • Maintain CMMS by updating records, creating new equipment/calibration plans, and generating, reviewing, and closing work orders in compliance with cGMP.
  • Support equipment commissioning, qualification, validation, and preventative maintenance shut-down activities.
  • Track alarm responses and prepare quarterly operational reports.
  • Assist with internal, customer, and regulatory audits, providing on-the-floor oversight and building management system monitoring during shutdowns.


Who You Are:

Minimum Qualifications:
  • Associate Degree in Chemistry, Biology, Controls Engineering, Mechanical Engineering or other Life Science or Engineering Discipline.

OR
  • Vocational degree or certification in industrial maintenance, electronics, or other trade and 1+ years of experience in a GMP manufacturing industrial role.

OR
  • High School Diploma or GED and 3+ years of experience in a GMP manufacturing industrial role.


Preferred Qualifications:
  • Bachelor's Degree in Engineering or Science discipline.
  • 2+ years of experience in cGMP Quality, Engineering, or Manufacturing.
  • Experience with TrackWise, Mango, SAP or other QMS and CMMS systems in cGMP environment.
  • Ability to work within a cross-functional team.
  • Effective oral and written communication skills.
  • Demonstrated use of Good Documentation Practices.
  • Strong computer and document management skills with sharp attention to detail.


Pay Range for this position: $31 - $48 / hour

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites. For more information click here.

RSREMD

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.

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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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