Manager, Facility Engineering - Marlborough, MA | Biospace
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Manager, Facility Engineering

Astellas

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Location:
Marlborough, MA
Posted Date:
9/7/2017
Position Type:
Full time
Job Code:
1750042509
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Description

The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma 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.

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

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 Marlborough, Massachusetts.

We are seeking a highly motivated Manager, Facilities Engineering.

The 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 will also be responsible for managing key GMP programs such as calibration, maintenance, and lifecycle management within a well-developed quality system for clinical and commercialized manufacturing.

The position will be actively involved in facility design, construction, and renovation by providing design input and oversight of construction activities.

Essential Responsibilities:

* Manage and plan projects in partnership with R&D, Technical Operations, and Commercial Operations stakeholders at the Astellas Institute for Regenerative Medicine (AIRM)

* Manage outside services who execute calibration, installation, commissioning, maintenance, and other GxP support services

* Manage 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

* Act as Owner's Representative and manage construction in multiple facilities to assure compliant activities with respect to safety, methodology, and fulfillment of specifications

* Develop, manage, and change facility documentation to support change controls

* Write SOP's based on solid understanding of regulatory (US, EU, JPN) requirements for the engineering function

* 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 engineers to accomplish functional objectives
* Works transversally in support of all Astellas functional teams at the AIRM site

* Direct impact on inspectional performance of the facility

* Direct impact on successful implementation and qualification of new systems

* Direct impact on site security and sustainability of key GMP systems

* Leader for educating on and supporting quality, safety, and environmental compliance

* Significant impact on the company's ability to meet strategic goals with respect to cost, performance, and timing

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

* Acts as a cross-functional change agent for all AIRM functional groups who have infrastructure, equipment, utility, software, or automation needs.

Requirements

Required:

* Minimum Bachelor's Degree in Engineering (Mechanical, Chemical, or other engineering aligned discipline)

* Experience working in commercialized biopharmaceutical operation in the engineering function

* Construction execution / supervision 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

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

Preferred:

* 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

Disclaimer

The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.

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