Sr Manager, Biopharma Facility Engineering

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Sr Manager, Biopharma Facility Engineering opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Sr. Manager, Facility Engineering reports to the Director, Facility Engineering and is responsible for execution of projects to change and improve building infrastructure, utility systems, equipment, and security. The position is also responsible for independently managing key GMP programs such as calibration, maintenance, and lifecycle management within a well-developed quality system for clinical and commercialized manufacturing. The position provides leadership for facility design, construction, and renovation by providing design input and oversight of construction activities.

Essential Job Responsibilities:

• Independently manage procedures, employees, and outside services to execute calibration, installation, commissioning, maintenance, cleanroom disinfection, and other GxP support services with full compliance.

• Independently manage GMP assets throughout their lifecycle from defining user requirements through decommissioning. Make recommendations for preventive maintenance programs, upgrades, and repairs. Assets will include facility spaces, cleanrooms, utilities, equipment, building automation.

• Independently develop and write SOPs based on solid understanding of regulatory (US< EU, JPN) requirements for the engineering function.

• Manage and plan GMP building alteration projects in partnership with end users and stakeholders at the Astellas Institute for Regenerative Medicine (AIRM).

• Act as Owner’s Representative and independently manage construction in multiple facilities to assure compliant activities with respect to safety, methodology, and fulfillment of specifications.

• In partnership with QA / Validation and/or outside contractors, execute facility, equipment, and automation qualifications.

• Lead commissioning activity and approve all commissioning protocols and final reports on behalf of Facility Engineering.

• Develop, manage, and change facility documentation to support change controls.

• Use facilitative leadership and collaborative skills in a team-oriented environment to lead and engage end users in successful facility development and operational changes.

• Directly manage one or more employees or contractors to accomplish functional objectives.

Quantitative Dimensions:

• Direct impact on cost and schedule of highly visible strategic projects.

• Direct impact on regulatory and inspectional performance of the facility.

• Direct impact on successful qualification outcomes for and existing new systems.

• Direct impact on site security and sustainability of key GMP systems.

• Leader for educating on and supporting quality, safety, and environmental compliance.

• Works transversally in support of all Astellas functional teams at the AIRM site.

• Significant impact on the company’s ability to meet strategic goals with respect to cost, performance, and timing.

Organizational Context:

• Reports to the Director, Facility Engineering in Westborough, Massachusetts.

• Partners with Facilities, Quality Assurance, Manufacturing, R&D and other groups to improve processes and asset performance.

• Acts as a cross-functional change agent for BioPharma functional groups who have GMP infrastructure, equipment, utility, software, or automation needs.

• Independently leads multiple Facility Engineering sub-functions (Calibration, Equipment Maintenance, Building Automation, GMP Janitorial, Utility Maintenance, Construction, Asset Management).

Qualifications Required:

• Education and background:

-BS in Engineering and >10 years’ experience, or

-BSET in Construction or Facility Management and >12 years’ experience, or

-HS Diploma with trade or facility management certification and > 18 years’ relevant experience.

• Demonstrated ability to lead and manage functional teams (direct reports) as well as 3rd party service providers.

• Successful track record for cross-functional leadership, facilitation, project management.

• Construction execution / supervision / administration experience in commercial buildings.

• Good written and verbal communication skills and experience communicating with all organizational levels.

Preferred:

• Experience working in commercialized biopharm operation in the facilities operations and/or engineering function.

• Commercial operations experience in cell therapy/regenerative medicine.

• Knowledge of US and EU aseptic processing regulations, especially as they apply to commercialized cell therapy and regenerative medicine.

• Advanced understanding of contamination control topics including cleanroom operation, HEPA filtration, disinfection, gowning, and proper material/personnel flow.

• Experience in current requirements for lifecycle management of GMP assets.

• Understanding of HVAC systems for pharmaceutical facilities.

• Experience with building automation, monitoring systems, asset management systems, security systems.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

Category Massachusetts TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans