Specialist, Facilities

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Job description

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Facilities Specialist primary role is to provide administrative support to the Facilities Department. This position reports to and supports the Facilities Resource Planning Manager.

This position is responsible for the on-time establishment of vendor service agreements and associated purchase requisitions for all vendors providing maintenance support services to the Canton site. In addition, this person is expected to provide financial reporting on these service accounts periodically.

The Facilities Specialist is also responsible for the management of site current good manufacturing practices (cGMP), non GMP cleaning and classified gowning for the cGMP production areas. Additional responsibilities include the onboarding of contracted cleaners and review of their required training to ensure they remain in compliance, as well as perform timely GMP/good documentation practices (GDP) logbook review for department activities.

The Facilities Specialist role also consists of executing work order administration tasks within the SAP Computerized Maintenance Management System (CMMS) to support the Canton Maintenance Program. The Facilities Specialist assists with the review and closure of corrective and preventative maintenance work orders from the SAP CMMS. This role will support quality documentation with respect to standard operating procedure (SOP) revisions, deviations, CAPAs, and Change Controls when required.

This position will have interactions with other key stakeholders such as Manufacturing Science and Technology (MSAT), Quality Assurance, Quality Control, Supply Chain, Environmental Health and Safety (EHS), Engineering, and Outside Contractors/Consultants.

ESSENTIAL FUNCTIONS
The ability to multi-task, evaluate, and prioritize work pertaining to site-wide maintenance is critical to the success of this role and the Facilities Department. A high level of organization is required for this role. This position requires knowledge of site compliance programs, with many being in or directly affecting GMP areas and environments. The GMP production environment requires attention to the details and accuracy within good documentation practices. The focus to create and maintain a safety culture that is proactive and striving for zero injuries is of the utmost importance and an expectation for all employees.

• Perform assigned Preventative and Corrective Maintenance on administrative processes and support systems.
• Scheduling, planning and maintenance event communications.
• Manage cGMP Clean Room and non-cGMP cleaning operations.
• Negotiate, create and maintain facilities services contracts and agreements.
• Maintain departmental accounting operations.
• Generation and closure of Quality Notifications with Deviations, CAPAs and Change Control documentation.
• Assist with capital and minor construction projects.
• Initiate purchase requisitions as required in SAP
• Provide evaluation of performance for department contractors
• Maintain compliance with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as cGMP, GDP, and Environmental Safety and Health and company regulations.
• Maintain a professional, courteous, respectful relationship with internal cross-functional customers; maintain a positive feedback/customer satisfaction rating.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor's Degree is preferable.
• Ability to work in an unsupervised environment
• Minimum of 4+ years of cGMP experience is required.
• Experience and working knowledge of Microsoft Project, Word, Excel required.
• Experience with SAP or another ERP/CMMS platform is required.
• Excellent organization and communication skills.
• Must have the ability to multi-task and coordinate workload by priority.
• Must be customer service and quality driven.
• Knowledge of FDA regulatory requirements pertaining to bio-processing facilities.
• Knowledge of Biotechnology and/or vaccine processes and equipment knowledge.

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.