BioPharma Manufacturing Facilities Compliance Specialist - Astellas Pharma
Westborough, MA
About the Job
BioPharma Manufacturing Facilities Compliance Specialist
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 BioPharma Manufacturing Facilities Compliance Specialist opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
The Facilities Compliance Specialist will be part of the Facility Engineering department supporting the Manufacturing, lab, warehouse, and administrative areas. This position will assist the Engineering team in delivering quality services to clients and the opportunity to collaborate with other teams in the operation of a state-of-the-art biotech facility. This role typically reports to either the Senior Supervisor, Maintenance & Metrology OR Manager, Facilities and Engineering.
Essential Job Responsibilities:
+ Create and maintain building and equipment maintenance schedules; coordinate with outside contractors for the service and repairs of equipment.
+ Perform review of calibration and maintenance work performed by internal team members and by external service providers to confirm maintenance records and service reports are following cGMP and to promote right-first-time performance.
+ Lead deviation investigations with Engineering and QA using formal root cause analysis tools to identify root cause, robust corrective / preventive actions.
+ Author and execute change controls to implement small facility and equipment changes.
+ Create and maintain master data in the CMMS for assets/equipment.
+ Address client inquiries and concerns ensuring timely, quality issue resolution, and service delivery
+ Assist in sourcing and negotiating with service vendors and suppliers through requesting, reviewing, and submitting bids and proposals and support the monitoring and assessment of vendor performance.
+ Help with measuring and reporting key performance indicators against service level agreements. Provide facilities helpdesk services on behalf of the client(s) and monitor internal/external workflow for all facilities cases to ensure consistent quality of service and work product.
+ Partner with internal customers, colleagues, and external support services to achieve department goals.
+ Generate and follow standard operating procedures. Support the Engineering team with issues and system improvements.
+ Understand and adhere to all internal and external regulations & policies.
+ Collaborate with account managers, internal customers, and vendors to meet deadlines and provide facilities project support & coordination as necessary
Quantitative Dimensions:
The Facilities Compliance Specialist is responsible for the integrity of calibration and maintenance records generated by 3rd party service providers. They are a vital link to the coordination and completion of service requests, agreements, and work orders. This position will support all facets of the various requests and a point of contact for updates. This position will have a strong and collaborative interface with QA.
Organizational Context:
The Facilities Compliance Specialist will typically report to the Senior Supervisor, Maintenance & Metrology OR Manager, Facilities and Engineering. Depending on the location, this role may report to the Department Head Facilities and Engineering. This role is expected to model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of the Astellas organization.
Qualifications:
Required:
+ High School diploma and 6+ years’ facilities coordination experience
+ Technical certificate/license or AA degree and 4+ years’ facilities coordination experience
+ BA/BS degree and 2+ years’ facilities coordination experience.
+ Proven experience working in cGMP facilities, project management, or real estate
+ Accomplished with technical writing (SOPs, maintenance procedures)
+ Proven experience reviewing GMP documentation for GDP and overall compliance integrity
+ Strong computer skills in Microsoft Office applications and other Facility Management systems; strong expertise and experience with a CMMS, including planning and scheduling
+ Strong GMP knowledge and understanding; good working knowledge of safety practices
+ Proven ability to multi-task and problem solves in a fast paced, demanding environment
+ Excellent communication skills, oral and written and an effective speaker before groups of customers and/or employees of organization
+ Excels with small project and vendor management
+ Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks, timelines, and priorities efficiently and effectively
+ Proven ability to manage change and make sound decisions under pressure, solve problems and deal with a variety of variables in situations where only limited standardization exists
+ Will support and demonstrate quality standards to ensure data of highest quality
+ Works closely with team and other functional key stakeholders on the Astellas Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned
Preferred:
+ Blue Mountain RAM experience
+ QA Compliance experience
Working Conditions:
+ This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, overhead reaching, and lifting up to 20 lbs.
+ This is an on-site role working in a cGMP regulated manufacturing facility.
+ On occasion, this role may travel to other Astellas manufacturing facilities (0-5%)
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
#LI-LK
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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 BioPharma Manufacturing Facilities Compliance Specialist opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
The Facilities Compliance Specialist will be part of the Facility Engineering department supporting the Manufacturing, lab, warehouse, and administrative areas. This position will assist the Engineering team in delivering quality services to clients and the opportunity to collaborate with other teams in the operation of a state-of-the-art biotech facility. This role typically reports to either the Senior Supervisor, Maintenance & Metrology OR Manager, Facilities and Engineering.
Essential Job Responsibilities:
+ Create and maintain building and equipment maintenance schedules; coordinate with outside contractors for the service and repairs of equipment.
+ Perform review of calibration and maintenance work performed by internal team members and by external service providers to confirm maintenance records and service reports are following cGMP and to promote right-first-time performance.
+ Lead deviation investigations with Engineering and QA using formal root cause analysis tools to identify root cause, robust corrective / preventive actions.
+ Author and execute change controls to implement small facility and equipment changes.
+ Create and maintain master data in the CMMS for assets/equipment.
+ Address client inquiries and concerns ensuring timely, quality issue resolution, and service delivery
+ Assist in sourcing and negotiating with service vendors and suppliers through requesting, reviewing, and submitting bids and proposals and support the monitoring and assessment of vendor performance.
+ Help with measuring and reporting key performance indicators against service level agreements. Provide facilities helpdesk services on behalf of the client(s) and monitor internal/external workflow for all facilities cases to ensure consistent quality of service and work product.
+ Partner with internal customers, colleagues, and external support services to achieve department goals.
+ Generate and follow standard operating procedures. Support the Engineering team with issues and system improvements.
+ Understand and adhere to all internal and external regulations & policies.
+ Collaborate with account managers, internal customers, and vendors to meet deadlines and provide facilities project support & coordination as necessary
Quantitative Dimensions:
The Facilities Compliance Specialist is responsible for the integrity of calibration and maintenance records generated by 3rd party service providers. They are a vital link to the coordination and completion of service requests, agreements, and work orders. This position will support all facets of the various requests and a point of contact for updates. This position will have a strong and collaborative interface with QA.
Organizational Context:
The Facilities Compliance Specialist will typically report to the Senior Supervisor, Maintenance & Metrology OR Manager, Facilities and Engineering. Depending on the location, this role may report to the Department Head Facilities and Engineering. This role is expected to model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of the Astellas organization.
Qualifications:
Required:
+ High School diploma and 6+ years’ facilities coordination experience
+ Technical certificate/license or AA degree and 4+ years’ facilities coordination experience
+ BA/BS degree and 2+ years’ facilities coordination experience.
+ Proven experience working in cGMP facilities, project management, or real estate
+ Accomplished with technical writing (SOPs, maintenance procedures)
+ Proven experience reviewing GMP documentation for GDP and overall compliance integrity
+ Strong computer skills in Microsoft Office applications and other Facility Management systems; strong expertise and experience with a CMMS, including planning and scheduling
+ Strong GMP knowledge and understanding; good working knowledge of safety practices
+ Proven ability to multi-task and problem solves in a fast paced, demanding environment
+ Excellent communication skills, oral and written and an effective speaker before groups of customers and/or employees of organization
+ Excels with small project and vendor management
+ Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks, timelines, and priorities efficiently and effectively
+ Proven ability to manage change and make sound decisions under pressure, solve problems and deal with a variety of variables in situations where only limited standardization exists
+ Will support and demonstrate quality standards to ensure data of highest quality
+ Works closely with team and other functional key stakeholders on the Astellas Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned
Preferred:
+ Blue Mountain RAM experience
+ QA Compliance experience
Working Conditions:
+ This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, overhead reaching, and lifting up to 20 lbs.
+ This is an on-site role working in a cGMP regulated manufacturing facility.
+ On occasion, this role may travel to other Astellas manufacturing facilities (0-5%)
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
#LI-LK
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Source : Astellas Pharma
