Senior Maintenance & GMP Compliance Engineer

Pfizer; Rochester (MI); On-site; USD 82,000 - 138,000; Full time

Benefits offered by this job

401(k) match

Paid vacation

Health benefits

Relocation assistance

Job summary

Pfizer in the United States is seeking a Senior Maintenance Compliance Engineer to join our on-site penicillin manufacturing facility. You will oversee maintenance and reliability activities for equipment, utilities, and production systems, ensuring compliant and safe operations that keep medicines flowing.

You will lead RCA and CAPA processes, develop scopes of work, and collaborate with Production and Quality teams to meet project targets.

Qualifications

• Bachelor's degree with at least 2 years experience, or a master's with more than 0+ years, or an associate's degree with 6 years of experience, or a 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.

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, foster a safe work culture.
• Actively participate in site & corporate initiatives.
• Leads and participates in investigations, change controls and develops/implements Corrective and Preventative Actions (CAPA's) for the maintenance department.
• Serve as a liaison between Quality Operations and engineering/maintenance departments to facilitate timely closure of investigations.
• Technical support for standard operating procedure improvements and updates.

Skills

Root Cause Failure Analysis

PM/PDM optimization

FMEA

GxP knowledge

MS Office

Engineering project management

Team collaboration

Education

Bachelor's degree

Master's degree

Associate degree

High school diploma

Tools

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Job description

Pfizer in the United States is seeking a Senior Maintenance Compliance Engineer to join our on-site penicillin manufacturing facility. You will oversee maintenance and reliability activities for equipment, utilities, and production systems, ensuring compliant and safe operations that keep medicines flowing.

You will lead RCA and CAPA processes, develop scopes of work, and collaborate with Production and Quality teams to meet project targets.