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GMP Utilities Asset Manager


Andover, MA
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Job Details


Provide engineering oversight and technical direction (for design, installation, startup/commissioning, testing, validation /qualification, operation and maintenance) of GMP utilities and systems within a biopharmaceutical manufacturing environment in Andover, Massachusetts. The GMP utilities in scope include Purified Water, WFI, Clean Steam, Process Gases, (Compressed Air, CO2 and O2) and HVAC systems.


+ The GMP Utilities Asset Manager is accountable for the management for the life cycle of the assets.

+ Provide detailed technical direction and robust design solutions to ensure continuous supply of utilities (Purified Water, WFI, Clean Steam, Process Gases and HVAC) to end users, ensuring quality and compliance specifications are met / exceeded.

+ Preparation of capital investment requirements to maintain asset reliability.

+ Financially responsible for Asset Cost Center which includes a budget to support Services/Supplies/Consumables/Utilities/Personnel

+ Provide good judgment and innovation by utilizing and adapting a broad knowledge of engineering principles and practices acquired through progressive experience.

+ Lead and provide technical engineering oversight to develop scope of work, project execution plans, and associated engineering studies for equipment / component installation, modification, replacement, in accordance with site specifications. Leverage site project management and change control and change management procedures to revise drawings, P&IDs, SOPs and develop initial validation program strategy with site partners.

+ Lead development of design, startup and test documents including User Requirement Specification (URS), Functional Requirement Specification (FRS), commissioning and qualification test plans, as applicable.

+ Provide technical trouble shooting support using Root Cause Failure Analysis (RCFA), Method 1 or Pfizer Human Performance investigations with good engineering practices and problem solving techniques.

+ Support proactive reliability assessments including data collection, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), HAZOP analysis and process improvement initiatives. Leverage data to optimize PM plans and materials of construction for robust asset performance.

+ Interface with External Clients, Auditors, Regulatory Agencies and Internal Partners and communicate effectively with all coworkers, clients, vendors, contractors, and visitors.

+ Support Quality system elements including but not limited to investigations, audits, change controls, revalidations, inspections etc. Participate in Environmental Review Committee (ERC) meetings and perform investigations, as necessary.

+ Lead Facility / Utility Shutdown efforts to complete planned preventive / corrective maintenance and capital projects.

+ Ensure that all work is performed in accordance with SOPs, cGMPs, safety procedures, quality standards, OSHA standards, other regulatory agency standards, and good maintenance practices.

+ Promote safety within the workplace by following site safety procedures and perform proactive safety assessments, foster a safe work culture. Incorporate safety, cGMP, and regulatory compliance into all job functions and recommendations.

+ People Leader Responsibilities

+ Foster a Safety Culture and exhibit leadership behaviour with safety samaratins to mitigate potential safety issues.

+ Promote "One Pfizer, One Site, Own It" mindset towards cross functional goals for robust delivery of POR

+ Promote a CI, Zero Defects mindset, by exhibiting leadership behaviors for direct staff

+ Accountable for performance management, talent development **,** coaching and feedback, developing clear performance expectations and priorities, conducting scheduled and adhoc performance reviews and assessments of direct reports.

+ Accountable for efficient and effective engineering resource planning, forecasting, prioritization for optimal allocation and utilization of available resources.

+ Evaluate need for outside services and provide oversight.

+ Work with Project and Contract Management Group to procure outside services.

+ Ensure staff has appropriate training and technical skils for assignments

+ Provide development opportunities, cross-functional training, mentoring and diversity with work assignments to staff

+ Hiring and retention


+ Candidate should have a BS/MS in Chemical or Mechanical Engineering or relevant discipline (ie. Biomechanical Engineering, Business Asset Management ) + minimum of 15 years of industry experience

+ Candidate must have a thorough in depth knowledge in design and operation of Purified Water, WFI, Clean Steam, generation / distribution systems in addition to Process Gases and HVAC in a cGMP biopharmaceutical environment

+ Candidate must be able to work across functional areas such as operations, maintenance, quality and regulatory.

+ Good communication skills, verbal and written, are required.

+ Working knowledge of automated systems with ability to troubleshoot.

+ Ability to read and generate documents such as Piping & Instrumentation Diagrams (P&IDs), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Configuration Specifications (CS), and Qualification documents.

+ Ability to communicate effectively with site leadership, stakeholders, plant partners, engineers and maintenance persons.

+ Ability to shift priorities according to changes in departmental/facility needs and be open to different ideas/approaches.

+ Be highly motivated, show initiative, and work well independently or in a team environment.

+ Software skills in using computer systems such as Microsoft Office.

+ Ability to analyze equipment failures using personal knowledge and internal and external resources.

**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.

**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.

**Other Job Details:**

+ **Last Date to Apply for Job: 1/4/2018**

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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