Engineering Compliance Manager

Pfizer•Sanford, NC
•$116,000 - $193,400•Onsite

About The Position

The Engineering Compliance Manager leads and oversees site engineering compliance programs to ensure adherence to regulatory requirements, corporate standards, quality systems, and industry best practices. The role provides strategic direction and governance for engineering documentation, maintenance compliance, asset management processes, calibration programs, inspection activities, and audit readiness. The manager partners with site departments to maintain compliance and drive continuous improvement and operational excellence. The position provides technical or business support to Engineering, Maintenance, Utilities, and Risk Management (EMU/RM), maintains EMU/RM documentation, oversees investigations and corrective and preventive actions, and supports audits, inspections, certifications, reporting, and compliance training. The work is on premise, in an office-based environment with routine excursions to job sites and utility or manufacturing areas. PPE and gowning requirements apply. Work outside normal business hours and on call may be needed for business reasons; periodic travel is rare but may be required for global engineering and network collaboration.

Requirements

  • Meet one of the following education and experience combinations: bachelor's degree and at least 4 years of experience; master's degree and at least 2 years; PhD and 0 or more years; associate's degree and 8 years; or high school diploma (or equivalent) and 10 years of relevant experience.
  • 5 or more years of demonstrated experience.
  • Knowledge of an Enterprise Asset Management solution or other CMMS applications.
  • Thorough knowledge and understanding of current Good Manufacturing Practices (cGMP), the Food and Drug Administration, other regulations, and current pharmaceutical industry standards.
  • Strong people management experience, communication skills, and leadership skills.
  • Ability to shift priorities in response to departmental or facility needs and openness to different ideas and approaches.
  • Adhere to PPE and gowning requirements.
  • Must be authorized to work in the United States by any employer; U.S. work visa sponsorship is not available. The position requires permanent U.S. work authorization.

Nice To Haves

  • Relevant pharmaceutical experience.

Responsibilities

  • Lead the site's Engineering Compliance Program and ensure adherence to regulatory, quality, safety, and corporate requirements.
  • Provide technical or business support to Engineering, Maintenance, Utilities, and Risk Management (EMU/RM).
  • Maintain EMU/RM documentation, including procedures, training materials, risk assessments, job descriptions, and engineering documents.
  • Ensure EMU investigations are conducted and closed in accordance with site and global procedures.
  • Ensure assets are enrolled in the computerized maintenance management system and maintain master data throughout the asset lifecycle.
  • Coordinate internal audits for EMU and coordinate responses.
  • Support EMU Board of Health inspections and RQA activities through response coordination and stakeholder engagement.
  • Manage EMU/RM quality metrics and reporting.
  • Support Risk Management audits and certifications.
  • Review and approve annual account recertifications for site automation systems.
  • Support ad hoc training programs implemented for compliance purposes.
  • Assist with coordination and execution of large-scale, cross-functional continuous improvement projects.
  • Ensure timely completion of corrective and preventive actions (CAPAs) related to engineering and maintenance compliance.

Benefits

  • 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.
  • Medical, prescription drug, dental, and vision coverage.
  • Eligible to participate in Pfizer’s Global Performance Plan with a bonus target of 15% of base salary.
  • Eligible to participate in a share-based long-term incentive program.
  • Relocation assistance may be available based on business needs and/or eligibility.
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