Sr. Reliability Engineer - Instrumentation

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

Working with Pfizer’s dynamic engineering team, you will play a critical part in managing the maintenance and reliability engineering activities involving the redesign, maintenance, and repair of utilities systems, buildings, and production/non-production equipment.

This role is responsible for leading the Andover Pfizer site Calibration Program, ensuring the program remains compliant with all cGMP requirements/ Pfizer Quality Standards (PQS) and strives towards best-in-class performance. 

Additionally, the Sr. Instrumentation Reliability Engineer is responsible for increasing reliability, sustainability, and maintainability of a GMP biopharmaceutical manufacturing facility with special focus on system aspects relating to instrumentation. Examples of supported systems include production equipment such as bioreactors, fermenters, ultrafiltration skids, Clean – In – Place (CIP) skids and facility equipment such as Air Handling Units (AHU), Water for injection (WFI) systems, Environmental Rooms, and other supporting equipment.

How You Will Achieve It

• Lead site calibration program to ensure program meets all regulatory Pfizer quality standards (PQS) requirements.

• Author, review, and/or Approve all standard operating procedures related to the calibration program and calibration maintenance

• Utilize the computerized maintenance management system (CMMS), Quality tracking system (QTS) for program metric calculations, failure investigations/RCA, work order generation, quality incident generation, and CAPA management/execution.

• Establish calibration program performance goals/metric and manages the achievement of these goals by working cross functionally as needed ( i.e. Maintenance, Engineering, Operations, Quality)

• Provide Management (EMU, Operations, and Quality) with routine calibration program metrics performance updates

• Technical support for regulatory agency audits and serve as a subject matter expert to defend the calibration program

• Drive continuous improvement of the calibration program

• Participates in internal and external Community of Practice discussions to share best practices and proposes opportunities for harmonization and simplification across the Pfizer network

• Lead and facilitate root cause analysis (RCA) of repetitive problems and investigate failures

• Facilitate and participate in equipment based Root Cause Failure Analysis (RCFA) investigations. 

• Evaluate CMMS work order data for repair trends and chronic issues and implement solutions. 

• Lead implementation of new instrumentation technology improvements and/or upgrades to production and infrastructure systems

• Executes all work within applicable standards, guidelines, and procedures

• Ensures individual training is up to date per site procedures

• Provide off-shift and on call support when necessary

• Lead or support all investigations and audits as needed

Qualifications

Must-Have

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.

• Candidates should have metrology experience in the biopharmaceutical or related industry

• Demonstrated time management skills, ability to work on multiple projects at a time

• Working knowledge of Engineering Document Management Systems

• Excellent interpersonal and communication skills with stakeholders, plant partners, engineers and maintenance persons

• Demonstrated ability to effectively lead and build teams across functions and levels in the organization

Nice-to-Have

• Competency of cGMP requirements relating to the management of a calibration program at a biopharmaceutical manufacturing facility 

• Industry experience (preferably as a Maintenance or Reliability Engineer ) with preventive and predictive maintenance programs is preferred.

• Preferred candidate should have hands on experience working with equipment and systems as a shop mechanic, technician, or plant engineer.

• Working knowledge of instrumentation, mechanical engineering and maintenance practices

• Possess strong leadership, organizational, interpersonal, oral and written communication skills.

• Ability to communicate effectively with engineers and shop craft-persons.

• Ability to instruct craftsmen and provide on the job training.

• Prioritizing multiple commitments and technical problem solving ability.

PHYSICAL/MENTAL REQUIREMENTS

• Candidate must be able to access clean room environments requiring clean room gowning (donning plant uniforms and coveralls).

• Candidate must be able to access mechanical spaces that require ascending/descending stairs and or ladders.

• Candidate may be required to access confined spaces.

• Ability to perform mathematical calculations as well as complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Minimal travel for investigating new technologies, vendor audits, etc.

• Ability to work off shift (Nights and Weekends) as needed

• Ability to work in a clean room environment

Other Job Details:

• Work Location Assignment: On Premise

• ​Relocation Support may be available based on business needs and/or eligibility.