Supervisor, GMP Maintenance - United States
Want to know company name or location? Company managed [?]
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
Supervisor, GMP Maintenance, 3rd shift.
- The GMP Maintenance Supervisor is accountable for supervising over Biomarin’s maintenance and facilities personnel who are responsible for operation and maintenance of utility systems as well as being responsible for performing maintenance of process equipment inside the Manufacturing suites. The Supervisor will work closely with manufacturing supervisors to provide excellent customer when repairs are required within the manufacturing suites, provide leadership for the individuals on the work teams, and collaborate with other departments and therefore must exhibit a strong sense of cross-functional teamwork and collaboration. Must have a strong skill set to communicate effectively with senior management. The Facilities supervisor will also be an active member of the Biomarin Emergency Response Team.
- Accountable decision maker that ensures that his / her teams perform tasks necessary to operate and maintain the plant in a safe manner while fully complying with company policies and various regulations (including cGMPs)
- Provide coaching, mentoring and timely feedback to staff to assist team members in achieving their full potential
- Provide instructions to individuals that are consistent with department goals and company policies
- Can articulate why policies and practices are important by tying actions back to company values
- Hold employees accountable by rewarding results that are obtained consistent with instructions, procedures, policies and values
- Serve as a role model for accountability, collaboration and customer service.
- Accountable for giving performance feedback to members of the facilities team for year-end performance reviews.
- Team member on the Biomarin Emergency Response Team.
Knowledge and Skills
- Sound knowledge of cGMP, safety and other regulations
- Exhibit strong judgement and decision making
- Demonstrated Utility, Process, Mechanical and Electrical knowledge
- Capable of interpreting engineering drawings and documents
- Ability to manage multiple complicated priorities / tasks
- Ability to interface, coordinate and oversee all types of maintenance and construction contractors
- Strong computer skills including CMMS / EAM programs
- Oversee and coordinate operation of GMP and non-GMP Utilities
- Water systems
- City water supply
- RO / DI Purified water generation and distribution
- WFI generation and distribution
- Plant steam boilers
- Pure steam generators
- 2 Megawatt CoGeneration facility
- Standby emergency diesel generators
- Compressed gases
- Waste water treatment systems
- Water systems
- Oversee and coordinate maintenance and repair of equipment and systems
- GMP and non-GMP Utility systems listed above
- Fixed equipment such as stainless steel tanks, piping and valves
- Process equipment including bioreactors (fixed and disposable), filtration systems, chromatography columns and cleaning skids
- Supervise the work of employees who repair and maintain building, facility, equipment and machinery
- Arrange for and manage appropriate third-party contract support, as needed
- Secure estimates and cost quotes when required
- Enforce sound safety and housekeeping practices
- Hire, train and oversee employees
- Organize schedules and assign work activities
- Develop and implement maintenance and operating procedures
- Investigate anomalies and incidents
- Prepare relevant reports
- Evaluate each team members performance
- Assist employees with related administrative and human resource issues
- Review and closure of work order documentation
- Able to lead area tours for various regulatory bodies including the FDA
- Support various regulatory audits
- Ensure closure of deviations and CAPAs
High school diploma is required
College degree is desired
5+ years of experience in a Biotech cGMP maintenance environment
Prior supervisory experience is desired
Ability to independently manage work, actions and expectation is essential
Strong organizational and communication skills
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.