ProBio-Facility Manager

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 position reports to the Director of Facility Engineering - GenScript ProBio, USA, and is responsible for the managing facility operations for the new cGMP Manufacturing site in East Hannover, NJ. This position is responsible for managing all facility operations, personnel, outside vendors and contractors and respective contracts required to maintain utility and manufacturing equipment and building maintenance for the new GMP manufacturing site in East Hanover. This position demands strong knowledge of facility utility systems (WFI, HVAC, Boilers, CCA, etc.) as well as GMP documentation. This is a great opportunity to develop and manage the facility operations function within a CDMO business, to support the manufacturing operations that deliver products to client projects that transform the lives of patients.
Position Information:

• Work Location: Piscataway, NJ / East Hanover, NJ
• Reports to: Director of Facility Engineering

Roles and Responsibilities:

1. Manage equipment/facility maintenance technicians and external service contractors.
2. Participate in the development and implementation strategies and departmental objectives.
3. Assist in the creation and execution of facility equipment installation qualifications, operational qualification, performance qualifications, yearly calibrations and preventive maintenance procedures.
4. Create, modify and track change control documentation to equipment and facilities.
5. Manage annual facility contracts.
6. Assist in applying for facility permits required from local, county, state and federal (i.e. air permit, wastewater discharge, storm water, hazardous/flammable material storage, boiler/chiller registration, etc.).
7. Participate in annual fire inspection, recycling inspection, county, FDA inspection and customer audits.
8. Provide verbal and written feedback on employee performance and sets employee objectives aligned with departmental goals.
9. Develop employee skills and support the employee's career development plans.
10. Perform other duties as assigned based on business needs.

Qualifications:

1. Bachelor's degree in Pharmaceutical Engineering, Mechanical Engineering, or equivalent.
2. 10+ years of facility management experience in a biotech/pharmaceutical cGMP production environment.
3. Understand essentials and requirements of quality management systems (QMS) used in GMP productions.
4. Ability to collaborate with all internal and external function groups, and adapt the priority and timeline change.
5. Strong interpersonal, verbal, and written communication skills.
6. Boiler Operation License - NJ High Pressure Black Seal or higher (optional).

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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.