Mechanical Engineer

What You Will Achieve

Provide engineering and technical support (for design, installation, startup/commissioning, testing, validation /qualification, operation and maintenance) of GMP utilities and systems within a biopharmaceutical manufacturing environment in Andover, Massachusetts. 
 

How You Will Achieve It

• Provide design and operational support of plant utility systems, including, HVAC, chillers, cooling towers, chilled water, glycol, heating hot water, and emergency tempered water distribution systems.
• Support maintenance work management and the design, installation, commissioning, qualification of equipment.
• Provide engineering support to develop scope of work, project execution plans, and associated engineering studies for equipment / component installation, modification, replacement, in accordance with site specifications. Revise drawings, P&IDs, SOPs and develop test plans leveraging site project management and change control procedures.
• Support the 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.
• Support 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.
• Provide off-shift and on call support when necessary
• Actively participate in site & corporate initiatives such as Communities of Practice, Limited Duration Teams.
   

Qualifications

Must-Have

• Minimum Requirements: Candidate should have a BS in Chemical or Mechanical Engineering or relevant discipline (ie. Biomechanical Engineering) + minimum of 3 years or MS/PhD + minimum of 2 years of industry experience.
• Candidate must be able to work across functional areas such as operations, maintenance, quality and regulatory.
• Good communication skills, verbal and written, are required.
• Ability to read and generate documents such as Piping & Instrumentation Diagrams (P&IDs), User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Qualification documents.
• Be highly motivated, show initiative, and work well independently or in a team environment.
• Demonstrate skills in using computer systems and software such as Microsoft Office Products.
• Demonstrate ability to analyze equipment failures using personal knowledge and internal and external resources.
   

Nice-to-Have

• Knowledge of plant utility systems, including, HVAC, chillers, cooling towers, chilled water, glycol, heating hot water, and emergency tempered water distribution systems in a cGMP biopharmaceutical environment.
• Ability to shift priorities according to changes in departmental/facility needs and be open to different ideas/approaches.
   

PHYSICAL/MENTAL REQUIREMENTS

Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis
 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel may be required at times. 
 

Other Job Details:

• Relocation support available

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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.

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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.

Engineering

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