Sr. Maintenance Compliance Engineer

USE YOUR POWER FOR PURPOSE

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.

Working with Pfizer’s dynamic maintenance/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.

As a Senior Maintenance Compliance Engineer, your knowledge and skills will contribute towards the goals and objectives of the 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.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

• 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.

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience; 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.

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

• 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.
• Requires good written, oral communication and presentation skills.
• Requires good planning, organizing, time management and team participation skills.

Regular

Work Schedule:

Standard (M-F) daytime. 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.

Non-Regular

Work Schedule:

At different times of the year, this position will work long hours for scheduled manufacturing shutdown periods and throughout the year may be required to work late with little notice as need arises when equipment is unexpectedly down.

Demonstrate proficiency in cGMP, GMP, software development life cycle, environmental, health and safety…