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Pfizer

GMP Utility Operations and Maintenance Leader

Experience

Associate, 1+ Years

Industry

Pharmaceutical and biotechnology

Employment Type

Full Time

Location

Andover, MA

Remote

No

Job Description


ROLE SUMMARY

The Utilities Operations and Maintenance Lead has accountability for leading assigned staff in the operation, maintenance, and alarm response of equipment such as vapor compression stills, reverse osmosis units, clean steam generators, water treatment equipment such as water softeners, mixed bed demineralizers, carbon filtration units, ultraviolet sterilizers, and Compressed Gases; Responsible for achieving targets and delivering and improving Operations and Maintenance safety, consistency, quality/compliance, cost standards and customer service. Responsible for planning, organizing, staffing, performance assessment, salary recommendations, and employee counseling for a group of employees typically with similar technical background. Ensures that work performed by the assigned staff is accurate, timely, efficient and compliant with corporate policies, plant SOPs, cGMP regulations, and FDA regulations. Leads and actively participates in investigations and continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, and safety and/or cycle time. Collaborates effectively with other functional SMEs to ensure production goals are met and investigations are expeditiously completed. Has an understanding of cost structure, budgeting process and department spend. The ultimate goal is to optimize resources and maximize effectiveness while ensuring quality and safety standards.


ROLE RESPONSIBILITIES

Organizational Leadership

  • Acts at all times in line with the Company values, particularly leadership, integrity and respect for people which incumbent must role model.
  • Ensure compliance with all appropriate regulatory requirements including local, state and federal for both current Good Manufacturing Practices (cGMP) and non-GMP environments
  • Coaches and provides guidance to employees on a timely basis regarding development and performance (behavior, skills and attitude) to form a high-performance team.
  • Responsible for recruiting, training and managing functionally based technical staff.
  • Works to develop staff and identify development opportunities, cross-functional training, mentoring and diverse opportunities with work assignments.
  • Accountable for quality of work performed. Implement resource management systems to direct activities to highest site priorities established in partnership with production and infrastructure engineering groups.
  • Evaluates the need for outside services and provide oversight of any external services and resources needed

  • Reliability Excellence

  • Provide technical support to engineering & maintenance personnel directed to the solution of plant machinery or equipment problems and recommend corrective actions. Develop recommendations for skills requirements of Maintenance personnel including appropriate training programs
  • Provides input and support for EAMS administration, as applicable, to establish Asset life cycle master plans for all major equipment classes.
  • Work with EMU functional area leadership on investigations to provide technical expertise from the equipment perspective and/or recommends corrective actions
  • Lead change by applying lean principles and Continuous Improvement methodology.
  • Provides recommendations and support on capital projects as applicable to assure appropriate equipment reliability maintenance is established as part of the project (i.e. criticality assessment, PM, PdM, spare parts, and failure analysis as appropriate)
  • Provides good judgment and innovation by utilizing and adapting a broad knowledge of maintenance and engineering principles and practices acquired through progressive experience.
  • Remain current in requirements of the ever-changing business environment inclusive of plan of record, capital budgeting and total cost of ownership including reliability.
  • Provides input into budget and metrics development including the identification of cost efficiencies
  • Represent Andover in all Pfizer engineering forums and site network engineering community engagements.

  • Compliance & Quality

  • Ensures compliance with all government and company regulatory requirements. Ensures application of cGMP compliance with respect to staff, shop floor and documentation. Trains staff, as applicable, on necessary compliance and quality requirements.
  • Provide support to regulatory inspections and projects
  • Prepares Management Investigation Reports (MIRs) regarding deviations in process tasks, as applicable.
  • Partners with the Quality and Operations personnel to investigate Manufacturing Incidents applying tools as CAPA to eliminate root cause in investigating, asapplicable.
  • Participates and may lead continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, safety and cycle time.
  • Works with cross-functional experts in resolving moderately complex problems.
  • Reviews, updates, and revises SOP's, as applicable.

  • Operational


    Ensures department resources are identified and allocated appropriately (including shift coverage, work schedules, allocation of overtime) to meet project timelines and production targets


    BASIC QUALIFICATIONS

  • Bachelor's Degree with minimum of 6 years experience plus demonstrated leadership experience is required
  • Knowledge of FDA, OSHA and EPA regulations applicable to the pharmaceutical industry
  • Maintenance and/or Engineering experience in a multi-faceted, highly complex, multi-shift biopharmaceutical manufacturing operation
  • Strong leadership and communication skills are needed. Demonstrated examples of key leadership competencies including: focus on performance, creating an inclusive environment, fostering open discussion and debate, manage change and the development of people
  • Ability to manage multiple tasks at any given time and working within a matrix organization is required

  • PREFERRED QUALIFICATIONS

  • 2 years people management experience is preferred
  • Managerial or Supervisory experience in Engineering / Manufacturing is desirable
  • Bachelor’s Degree in Engineering or Sciences is desirable
  • CMRP / CPMM is desirable
  • Experience with cGMP practices. Working knowledge of clean steam generation and water purification equipment preferred.

  •  PHYSICAL/MENTAL REQUIREMENTS

  • Incumbent’s primarily work environment is varied with time allocated inside and outside all buildings of this complex and includes potential exposure to hazardous materials and energy sources requires the appropriate use of Personal Protection Equipment
  • Work involves direct contact with utilities and process equipment including, but is not limited to, high purity water systems including WFI, sanitary distribution, clean steam, process gases, and process control systems.

  • NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • ~5% travel for global engineering and network collaboration
  • Adherence to PPE and gowning requirements
  • Ability to work outside normal business hours and on call as needed for business reasons

  • Other Job Details:

  • Last Date to Apply for Job: 9/30/21


  • Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.



    Sunshine Act

    Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



    EEO & Employment Eligibility

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.



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