1+ months

Sr. Manager, Facilities & Maintenance

Canton, MA 02021


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 Sr. Manager of Facilities Services ensures equipment/systems, buildings and campus are maintained to continually meet engineering specifications, company quality standards, current industry guidelines and regulatory expectations. The Facilities Team is an integral part of design, procurement, installation, startup, and ongoing maintenance and calibration documentation which serves as proof of compliance to regulatory agencies (FDA and EU). Facilities employees serve as technical Subject Mater Experts (SMEs) for the Manufacturing Facility, Equipment, Utilities and Process. The department executes preventative and corrective work and supports improvement projects in the Facility, Process and Qualification program to enhance compliance, reduce costs, improve customer service, increase quality, and strengthen technical base.

Sr Manager of Facility Services leads the day-to-day operations in collaboration with our internal stakeholders. This includes the direct oversight to the General Maintenance, Production Support, Metrology, and Facility Resource Planning groups. Facilities Operations are accomplished through a department of technical staff, which includes both Emergent employees, and external service and trades contractors. This position manages performance and development of direct reports to ensure achievement of organizational and departmental goals and to create a collaborative, diverse and inclusive environment within the company. The Sr. Manager of Facilities Services is responsible for collaborating with engineering on the long-term strategic development to ensure ongoing asset availability, efficiency and reliability and continued compliance for the department.

The Sr. Manager of Facilities supports the unique needs of a cGMP licensed production facility. This position is primarily a 1st shift position, but this person must be able to support off shift and weekend efforts as they occasionally arise. This is a highly customer focused role, with responsibilities ranging from cGMP manufacturing and testing operations, to managing shutdowns, to oversight of janitorial and boiler operations, to managing systems and conditions to ensure a safe workforce.

The Canton location is a licensed commercial GMP biopharmaceutical manufacturing facility with operations including manufacturing of bulk biological drug substance.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Leadership Skills

  • Provide direct oversight to the General Maintenance, Manufacturing Support, Metrology, and Facility Resource Planning groups
  • Develops Managers, Individual Contributors, and technical experts
  • Continuously improve the safety, quality, and cost of Facility Services processes and practices.
  • Reputation as high performing leader with sustained performance and accomplishment.
  • Provide customer focus supporting engineering, research and development, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert and leader of the Facilities Services department.
  • Ensure equipment, facilities, infrastructure systems, and grounds are maintained in accordance with best industry practices.
  • Maintain adequate staffing, appropriate training, and availability of needed tools to deliver department objectives.
  • Develop and executes department succession plan.
  • Enforce employee adherence to all company, site, and department policies and procedures.
  • Is the primary interface for internal stakeholders and regulators for Facilities related topics.
  • Ensure the safety of employees, visitors, and contractors.
  • Ensure effective and timely completion of all Quality Systems within the department (deviations, CAPAs, change controls and routine SOP revisions).
  • Maintain all departmental documents.
  • Leads and works on interdisciplinary teams to complete site initiatives.
  • Maintain engagement and participation on the Canton site Extended Leadership Team (ELT).
  • Manage and directs work for assigned projects ensuring activities are on time, within budget, uphold safety culture and meet GxP and company requirements.
  • Oversee routine facility and campus shutdowns.
  • Develop and manage to departmental budgets.
  • Participates in review of contract negotiations for potential customers (specific to review of sections pertaining to Facilities).
  • Provide input into site planning processes (i.e. capital planning, site master plan, etc.) and oversee planning of departmental goals and objectives.
  • Responsible for resource management and resource modeling for equipment, instrumentation, supplies, and personnel in support of projects and initiatives.
  • Define metrics that exhibit productivity and throughput in functional area and maintains those established metrics.
  • Communicates metrics, trends, and data summaries to senior management using a variety of media: intranet, reports, and presentations.
  • Conducts personnel interviews, performance reviews, develops and administers development plans, performs follow-up on personnel issues, and provides feedback to group.
  • Performs all functions associated with recruitment and hiring process for Facilities Team positions (full-time, part-time, and temporary).
  • Maintain positive, professional relationships between Facility Services and their stakeholders, contractor and suppliers.


Technical Expertise

  • Develop an efficient and robust strategy for maintaining qualification status and uptime of all equipment and critical systems in a Pharmaceutical GMP facility.
  • Demonstrated success in technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing.
  • Reviews and approve supporting documentation of the Facilities and Maintenance QMS, which require facilities requirements awareness, or oversite, ensuring compliance of site within the Facilities and Maintenance QMS.
  • Possesses strong knowledge of current facilities industry best practices, including governmental regulations and GxPs.
  • Processes strong knowledge of bio-process industries and regulations.
  • Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies.
  • SME oversite of all disciplines within Facilities Services: Electrical, HVAC, Controls, Metrology, SAP Plant maintenance administration, Facilities Resource Planning, Production Support, boiler operations, General Maintenance (plumbing, pipefitting and carpentry) and contract janitorial and pest control services.
  • Represents Facility Services on projects and in addressing issues. Develop and recommend solutions outside general practices with a focus on continuous improvement and compliance.


Problem Solving

  • Initiates changes as required in the Facilities Services programs to enhance compliance, reduce costs, improve customer service, and strengthen technical base.
  • Collaborates with various departments to reduce product cost and increase productivity while sustaining or improving the validated systems.
  • Provide review for items supporting the Facilities and Maintenance Quality Management System.
  • Proposes unique solutions to complex problems using technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing.
  • Supports and owns process troubleshooting, operations support, root cause analysis, and risk assessment.
  • Is an SME for and uses proven monitoring and problem-solving techniques for root cause analysis (RCA) such as SPC fishbone, FMEA, 5-Why, etc.
  • Determine methods and procedures on complex assignments and implement them after obtaining necessary stakeholder approvals.
  • Determining methods and procedures on complex assignments and providing technical direction and guidance to engineers within the Facilities Services department.


The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Minimum Requirements:

  • 10+ years of experience in a biopharmaceutical environment with at least 3+ years in a leadership role.
  • Bachelors degree in business, science, engineering or related field. Other disciplines and/or equivalent job experience will be considered.
  • Excellent written and verbal communication skills.
  • Excellent organization and project management skills.
  • The ability to develop and manage good working relationships with internal departments and stakeholders, contractors, suppliers and regulatory inspectors.
  • Experience with budget preparation and scheduling.
  • Subject Matter Expertise for the following Facility Services disciplines: Electrical, HVAC, Plant Steam/boiler operations, Clean Steam, Water for Injection (WFI), Pre-treatment water systems, compressed air systems, Metrology, SAP Plant maintenance administration, Facilities Resource Planning, Production Support, General Maintenance (plumbing, pipefitting and carpentry), contract janitorial and pest control services.
  • Proficiency in Microsoft Project, Word, and Excel.
  • Must be customer service and quality driven.
  • Working knowledge of mechanical systems and maintenance practices.
  • SAP platform (plant maintenance) experience
  • Must have the ability to multi-task and coordinate workload by priority.

Preferred

  • Education: MS preferably in Science or Engineering discipline.
  • Experience: Minimum of 15 years of vaccine bioprocessing pharmaceutical cGMP experience with increasing responsibilities.
  • Experience: Previous experience working with FDA, EU, ICH and participating in regulatory agency inspections.
  • Experience: Lean / 6 Sigma experience
  • Experience: Highly desirable to have prior experience with developing and maintaining department budgets.
  • Experience: 5 years of leadership experience leading managers and/or supervisors and individual contributors preferred.
  • Knowledge: Must have competence of cGMPs.
  • Skills: Must have SOP, investigation, and project management skills and demonstrated ability to critically evaluate content of such documents
  • Skills: Must have personnel management skills
  • Skills: Must have good written communication skills. The ability to tailor communications to all levels in department and prepare appropriate updates to senior management and executive management. Must have effective communication skills for upward and downward audiences.
  • Abilities: Must be able to prepare reports for internal metrics and technical content; and prepare reports and data summaries for FDA review. Must determine appropriate content and criticality of information
  • Abilities: Must have good verbal skills. The ability to communicate clearly and extemporaneously to a variety of audience types. Must be able to act as representative for the function and develop others to communicate effectively

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Categories

Industry

  • Biotechnology
Posted: 2022-04-04 Expires: 2022-06-10

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Sr. Manager, Facilities & Maintenance

Emergent BioSolutions Inc.
Canton, MA 02021

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