Mechanical Maintenance Engineer

1 week ago

Rapid City, South Dakota, United States GenScript Full time
Job Overview

Company Overview

GenScript Biotech Corporation is a leading global biotechnology organization, founded in 2002, with a robust presence across various regions including North America, Europe, Greater China, and Asia Pacific. Our operations are centered around advanced gene synthesis technology, encompassing services as a Life Science Contract Research Organization (CRO), development of enzyme and synthetic biology products, biologics manufacturing, and cell therapy solutions.

At GenScript, we are dedicated to our mission of enhancing the health of humanity and nature through innovative biotechnology solutions.

About GenScript ProBio

As a subsidiary of GenScript Biotech Corporation, GenScript ProBio specializes in comprehensive Contract Development and Manufacturing Organization (CDMO) services, guiding clients from drug discovery through to commercialization. Our expertise spans cell and gene therapy (CGT), vaccine development, biologics discovery, and antibody protein drug manufacturing, ensuring efficient and effective drug development processes. Our capabilities in cell and gene therapy include CMC for IND submissions and both clinical and commercial manufacturing. We are recognized for our support of numerous clinical approvals for CGT drugs, including mRNA vaccines and CAR-T therapies.

Position Summary: The Mechanical Maintenance Engineer plays a crucial role in maintaining the operational integrity of manufacturing and laboratory equipment. This position involves executing and supervising maintenance activities in alignment with Good Manufacturing Practices (GMP) and the company's Standard Operating Procedures (SOPs), ensuring all actions are thoroughly documented.

Key Responsibilities:

  • Conduct daily monitoring, preventative maintenance, and repairs of manufacturing and laboratory equipment in accordance with established SOPs, ensuring minimal disruption to production schedules.
  • Perform corrective and preventative maintenance, including calibration of both GMP and non-GMP equipment.
  • Collaborate with various departments to troubleshoot, test, and optimize instruments and control systems.
  • Engage in continuous improvement initiatives within the site’s Maintenance Program.
  • Assist in maintaining and reviewing calibration standards and vendor documentation.
  • Support the start-up, commissioning, and handover of new systems.
  • Carry out preventative and predictive maintenance on clean utilities and systems that support manufacturing processes.
  • Oversee the maintenance of water rooms and associated equipment, including pumps, motors, and water purification systems.
  • Manage the upkeep of all site refrigeration units.
  • Troubleshoot and repair clean utility equipment and systems.
  • Maintain comprehensive documentation and records for all validated equipment and systems.
  • Coordinate with other departments and contractors for scheduled repairs and maintenance of clean utility systems.
  • Ensure training records are current and up to date.
  • Communicate necessary changes in documentation to management.
  • Adhere to current Good Manufacturing Practices (cGMPs).
  • Facilitate communication and coordination among departments during planned and unplanned maintenance activities.
  • Perform additional tasks as assigned by management.

Qualifications:

  • High School diploma with a minimum of 6 years of experience in facilities maintenance or operations within a pharmaceutical or biotechnology environment, or an equivalent combination of education and experience.
  • Advanced knowledge of Preventive Maintenance and calibration practices in a cGMP setting.
  • Familiarity with cGMP, GXP, Good Automated Manufacturing Practice (GAMP), and Software Development Life Cycle (SDLC) regulations.
  • Proficient in Computerized Maintenance Management Systems (CMMS) and Microsoft Office.
  • Strong verbal and written communication skills.
  • Ability to work both independently and collaboratively in a dynamic team environment.
  • Analytical mindset with strong problem-solving capabilities and adaptability to changing priorities.
  • Excellent organizational and time management skills, with the ability to manage multiple projects effectively.
  • Background in refrigeration technology is a plus but not mandatory.

GenScript USA Inc./GenScript ProBio USA Inc. is an equal opportunity employer committed to fostering a diverse and inclusive workforce. We ensure equal employment opportunities without discrimination based on any characteristic protected by law.

GenScript USA Inc./GenScript ProBio USA Inc. maintains a drug-free workplace.

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