Sr Manager / AD - GMP Facilities
JOB SUMMARY: This position will have accountability for all GMP supporting functions for the Maintenance, Metrology, Engineering and Validation groups serving the manufacturing space as well as being responsible for building the team that will ultimately own and operate the systems and equipment. Initially, the position will serve as a subject matter expert in monitoring the design and construction phase of the project buildout while developing the needed internal business processes such as GMP calibration and preventative maintenance programs. The position will work closely with the other Brisbane project user groups and management in support of meeting project timelines and goals. ESSENTIAL FUNCTIONS:
- Provide structure and leadership for newly formed internal GMP Facilities group
- Serve as a SME for all GMP Facilities related design, construction and operational needs for the Brisbane and potentially future sites
- Partner with other operational functions to ensure success of project goals and GMP readiness and compliance
- Develop, implement and own a comprehensive engineering, maintenance and facility strategy for the site, and the supporting policies and procedures.
- Recruit top talent with every hiring opportunity and motivate and develop members of the department to be key leaders within the organization.
- Actively influence and participate in the site leadership team and establishing effective cross-functional leadership relationships and presence.
- Contribute to the company’s overall growth strategy, develop plant & equipment investment plans and oversee the departmental budget and headcount, as well as the site’s capital expenditure budget. Plan strategically for potential new GMP warehousing capabilities.
- Maximize the success rate for production operations by instituting programs to minimize mechanical failure and enhance equipment performance.
- Ensure that appropriate training of all engineering and facilities personnel on equipment, process and facility safety procedures is maintained and up-to-date.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Bachelordegree in Engineering or other related science. Equivalent work experience may be considered.
- Experience working in GxP pharmaceutical and/or biotechnology regulated environment (8 years for Senior Manager or 10+ years for Associate Director)
- Experience in representing as SME and defending GxP systems in audit setting
- Highly functional in a fast-paced dynamic company with the ability to prioritize issues under differing pressures and to work collaboratively with cross-functional teams.
- Excellent written and verbal communication skills is a must
- Substantial operational engineering experience
- Working knowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards
- Demonstrated application of quality improvement methods such as LEAN, Six Sigma preferred
- Experienced working on all aspects of capital projects, including budgeting, design, construction, validation, start-up and ongoing operations.
- Experience in Central Utilities including, but not limited to: WFI, and purified water, compressed air, N2, chilled water, steam, heating hot water, electricity and sewage
- Proven leadership skills
- Exceptional project management skills