Responsible for the operation and maintenance of all B5 Fractionation manufacturing and support equipment. Applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the effective maintenance of the equipment and supervision of Maintenance Supervisors. Plans, executes and functionally directs important operational and or maintenance assignments, which require independent judgment. Assure cGMPs, SOPs, Division Procedures and Good Engineering Practices are appropriately followed in all maintenance activities. The incumbent has the responsibility and accountability to keep the facility and equipment in the assigned area operating in effective and compliant manner. Essential Duties and Responsibilities
- Lead, Manage, Administer and Monitor the Maintenance Supervisors to assure efficient and compliant operation and maintenance of all manufacturing equipment operated by the department.
- Oversee and Manage B5 Fractionation equipment failure investigations to ensure timely resolution of any issues thus assuring a continuous state of compliance with all applicable standards, methods, procedures, licenses and regulations.
- Identify, Lead, Influence, Drive and Support improvements that result in stable, reliable, and efficient operations.
- Search, Study, Identify and Understand all cost drivers for the B5 maintenance operation in order to reduce cost of operation year over year.
- Oversee and Manage B5 Fractionation Engineering Projects that enhance reliability for all B5 Fractionation manufacturing equipment according to project demand.
- Track, Monitor, Assess and Report operating and performance data that give insight and indication of the stability and robustness of B5 Fractionation and Pharma manufacturing equipment on an ongoing and forward-looking basis.
- Complete, Administer and Manage all documentation to support change control and design work.
- Facilitate and verify appropriate training for all employees on the shift (including but not limited to cGMPs, job skills, safety, etc.).Coordinate training as needed.
- Ensure assigned projects and deliverables (i.e. corrective actions, exception reports, meeting action items, etc.) are completed per the commitment date.
- Drive performance with employees by providing a positive and equitable work environment emphasizing respect, responsiveness, and results, as well as, utilizing the talent management process.
- Coordinate, oversee and manage contractors as needed to meet the responsibilities of the department.
- Maintain equipment in sound condition, report deficiencies and record in JDE.
Education and/or experience
- Must be well versed in engineering disciplines (e.g. fluid flow, thermodynamics, heat transfer, static and dynamics, engineering materials).Must possess knowledge of related disciplines.
- Must have strong aptitude for operation and controls of manufacturing equipment and processes.
- Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel of all levels.
- Must be able to work and facilitate a team-oriented environment.
- Must possess problem-solving skills.
- Must have organizational and administrative skills.
- Must have strong communication skills (both verbal and written).
- Must have demonstrated ability to manage multiple priorities in a manufacturing setting and prioritize responsibilities of self and direct reports appropriately.
- Must have the ability to analyze and interpret scientific and statistical data.
- Must have ability to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
- Must be well versed in purchasing practices and cost management.
- Proficient with Computer Maintenance Management Systems
- Must have experience with Microsoft Office applications.
- May be required to supervise multiple groups.
- BS degree required (Engineering or other technical field).
- 8+ years of relevant technical experience.
- Minimum 5 years relevant experience in managing facilities/maintenance employees and activities.
- FDA/cGMP experience preferred.
- Must be able lift, push pull up to 25 lbs. and carry up to 10 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold, wet environment
- Must be able to work multiple shifts, including weekends.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.