Engineer, Mechanical Maintenance

1 month ago

Pennington, United States GenScript Full time
Job DescriptionJob Description

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology

About GenScript ProBio

GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, GenScript ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, GenScript ProBio has a stable and high-yield viral vector platform.

Job Scope: The Engineer, Mechanical Maintenance is responsible for the manufacturing and laboratory equipment at the site. This includes performing activities and overseeing outside vendor activities required to support the Preventative Maintenance and Corrective Maintenance program in accordance with Good Manufacturing Procedures (GMP) regulations and company Standard Operating Procedures (SOPs). This includes ensuring that these activities are properly documented.

Essential responsibilities: Performs daily monitoring, preventative maintenance, and repairs of manufacturing and laboratory equipment in aP), Non-GMP process and laboratory areas.ccordance with SOPs, ensures proper documentation practices are followed and ensures that there is minimal or no interruption in the daily manufacturing schedules.

  • Maintains and performs corrective and preventative maintenance and calibrations on GMP and non-GMP equipment.
  • Supports other departments to troubleshoot, test, repair and optimize instruments, equipment and control systems.
  • Participates in the continuous improvement efforts within the site Maintenance Program.
  • Assists in the maintenance and review of calibration standards and vendor calibration documentation.
  • Provides support for start-up, commissioning, and turnover of new systems.
  • Perform preventative and predictive maintenance on related clean utilities and systems that support Process Manufacturing.
  • Maintains water rooms and related equipment. This includes, but may not be limited to, pumps, motors, Deionized Water System, WFI stills, Clean Steam Generators and related piping.
  • Maintains all site refrigerators and freezers.
  • Troubleshoots and repairs all related clean utility equipment and systems and Water for Injection (WFI) point of use flushing.
  • Maintains documents and records on all validated equipment and systems.
  • Interfaces with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems.
  • Maintains up to date training records.
  • Communicates with management regarding change documentation, as necessary.
  • Follows current Good Manufacturing Practices (cGMPs).
  • Communicates and coordinates with each department and within Facilities Management when planned and unplanned work events occur.
  • Performs other tasks and assignments as needed and specified by management.

Qualifications:

  • A High School diploma and a minimum of 6 years of facilities maintenance/operations experience in a pharmaceutical, biotechnology or related environment OR the equivalent combination of education and experience. Advanced knowledge of Preventive Maintenance and calibration disciplines within a cGMP Biotechnology, Pharmaceutical or related manufacturing environment.
  • Knowledge of cGMP, GXP, Good Automated Manufacturing Practice (GAMP), Software Development Life
  • Cycle (SDLC) regulations, knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
  • Proficiency with Computerized Maintenance Management Systems (CMMS).
  • Proficiency with Microsoft Office.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Refrigeration Technician background a plus but not required.

#LW

GenScript USA Inc/GenScript ProBio USA Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

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

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