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.
Organizational LeadershipActs 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 environmentsCoaches 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 ExcellenceProvide 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 programsProvides 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 actionsLead 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 efficienciesRepresent Andover in all Pfizer engineering forums and site network engineering community engagements.
Compliance & QualityEnsures 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 projectsPrepares 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.
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 requiredKnowledge of FDA, OSHA and EPA regulations applicable to the pharmaceutical industryMaintenance and/or Engineering experience in a multi-faceted, highly complex, multi-shift biopharmaceutical manufacturing operationStrong 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 peopleAbility to manage multiple tasks at any given time and working within a matrix organization is required
PREFERRED QUALIFICATIONS2 years people management experience is preferredManagerial or Supervisory experience in Engineering / Manufacturing is desirableBachelor’s Degree in Engineering or Sciences is desirableCMRP / CPMM is desirableExperience with cGMP practices. Working knowledge of clean steam generation and water purification equipment preferred.
PHYSICAL/MENTAL REQUIREMENTSIncumbent’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 EquipmentWork 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 collaborationAdherence to PPE and gowning requirementsAbility 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
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