Sr. Maintenance Compliance Engineer

Rochester, Michigan, United States – Full-time

About the role

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.

As a Senior Maintenance Compliance Engineer, your knowledge and skills will contribute towards the goals and objectives of the maintenance/engineering team. Your ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in managing difficult issues and establishing consensus between teams.

Responsibilities

• Contribute to completion of projects, manage time to meet targets, develop plans for short-term and mid-term work activities on projects.
• Provide engineering support to develop scope of work, project execution plans, and associated engineering studies for equipment and component installation, modification, etc.
• Provide necessary operational support as needed.
• Review preventive and corrective work order activities, provide equipment maintenance history review, and work on preventive maintenance improvements.
• Manage technical writing and document review.
• Ensure maintenance/engineering compliance with Current Good Manufacturing Practices (part of GxP), contemporary technologies, and best aseptic practices.
• Participate in equipment/system-based Root Cause Failure Analysis (RCFA) investigations and update equipment reliability plans.
• Partner with Production and Quality Team Leads on troubleshooting and scheduling.
• Promote safety within the workplace by following site safety procedures and perform proactive safety assessments, fostering a safe work culture.
• Actively participate in site & corporate initiatives.
• Lead and participate in investigations, change controls, and develop/implement Corrective and Preventative Actions (CAPAs) for the maintenance department.
• Serve as a liaison between Quality Operations and engineering/maintenance departments to facilitate timely closure of investigations.
• Provide technical support for standard operating procedure improvements and updates.

Requirements

• Applicant must have one of the following:
  • Bachelor’s degree with at least 2 years of experience; OR
  • Master’s degree with 0+ years of experience; OR
  • Associate’s degree with 6 years of experience; OR
  • High school diploma (or equivalent) and 8 years of relevant experience.
• Experience with Root Cause Failure Analysis, Equipment Criticality Ranking, PM/PDM optimization, and/or Failure Modes and Effects Analysis.
• Demonstrated experience in manufacturing / reliability engineering, plant engineering, and/or project engineering.
• Teamwork spirit, good communication skills, and training abilities.
• Excellent interpersonal effectiveness and communication skills (written and oral).
• Working knowledge of MS Office Applications.
• Strong knowledge and understanding of Current Good Manufacturing Practices.

Preferred Qualifications

• Certified Maintenance and Reliability Professional (CMRP) or equivalent (desired but not required).
• Experience with pharmaceutical manufacturing equipment and/or utility systems.

Physical/Mental Requirements

• This is an on-site role at a penicillin manufacturing facility. Candidates must not be allergic to penicillin.
• Lifting, sitting, standing, walking, bending.
• Ability to perform mathematical calculations and complex data analysis, problem solving.
• Ability to work in clean room conditions.
• Ability to write general correspondence and technical reports.
• Good written, oral communication, and presentation skills.
• Good planning, organizing, time management, and team participation skills.

Schedule

• Standard (Monday–Friday) daytime schedule. Overtime work may be required.
• Work requires on-site presence.
• Occasional national/international travel for equipment factory acceptance testing, training seminars, vendor meetings, work progress meetings, etc.
• At different times of the year, this position will work long hours for scheduled manufacturing shutdown periods and may be required to work late with little notice when equipment is unexpectedly down.

Pay

The annual base salary for this position ranges from $82,700 to $137,900. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary.

Benefits

• Comprehensive and generous benefits including a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits to include medical, prescription drug, dental, and vision coverage.
• Relocation assistance may be available based on business needs and/or eligibility.