PCI Pharma Services

Manager, Facilities and Metrology

PCI Pharma Services

full-time

Posted on:

Location Type: Office

Location: Madison • Wisconsin • United States

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About the role

  • Ensures all aspects of facilities and metrology are adhering to cGMPS and PCI’s established SOPs.
  • Make the necessary recommendations and changes to improve process efficiencies.
  • Ensures all projects are executed safely, on time, and within budget.
  • Responsible for all aspects of facilities and calibration programs.
  • Oversee the departmental budget and headcount.
  • Provides coaching, mentoring and development to each direct report both in execution of their group responsibilities and in their own development.
  • Provides leadership to ensure facilities and calibration supports manufacturing operations in a fashion that focuses on quality and adherence to the schedule in support of Operations.
  • Assures compliant and timely completion of all quality documents (Deviations, CAPAs, Change Controls, etc.) assigned to the facilities and calibrations team.
  • Support a variety of regulatory and client audits.
  • Ensures team training and performance compliance with all corporate policies and procedures.
  • Provides guidance to people managers in the areas of compliance, safety, deviations, corrective and preventive actions, and investigations related to facilities and calibration areas.
  • Works closely with key functions such as Quality, Manufacturing, EH&S, Sales/Project Management, Engineering, and Global PMO to ensure internal and external clients’ requirements are met.
  • Analyzes existing processes/unit operations and determines modifications necessary to improve safety, as needed and streamline processes.
  • Responsible for on time calibration schedules for Madison site.
  • Advanced knowledge and understanding of PLC programming and integration.
  • Direct assigned personnel, including performance evaluations, scheduling, orientation and training.
  • Recommends employee hires, transfers, promotions, salary changes, discipline, termination and similar actions, as appropriate.
  • Maintains the professional competence, knowledge and skills necessary for the satisfactory performance of all assigned responsibilities.
  • Provides leadership in analyzing and developing improvements in process efficiency, quality, safety and client relationships (internal and external).
  • Correctly implements industry best practices that will successfully withstand regulatory inspections by regulatory authorities.

Requirements

  • 5+ years of experience in the field of technical facilities or metrology in the biopharma/pharm and/or medical device facilities and proven leadership experience.
  • Bachelor’s degree in engineering, chemistry, biology, or related technical discipline or equivalent combination of work experience and schooling/certifications.
  • 3+ years management/leadership experience.
  • Operational background in cGMP environment, preferably in aseptic manufacturing / facilities.
  • Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources.
  • Experience with direct exposure to Customers in a CDMO business is a plus.
  • Demonstrate commitment to continuous improvement at all levels within the organization.
  • Excellent organizational skills
  • Experience in the Management of 5+ people
  • Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines
  • Excellent verbal and written communication skills.
  • Ability to effectively manage multiple projects, teams and technical staff at all levels.
  • Ability to assess and develop organizational talent which includes engaging employees and driving technical and personal development.
  • Setting future leadership for success.
  • Performance measurement and KPI Tracking and Reporting.
  • Proficiency with MS Office suite is preferable.
Benefits
  • Health insurance
  • Paid time off
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
PLC programmingcalibration programsprocess efficiencyquality document completioncGMP complianceCAPA managementdeviation managementsafety analysisproject managementbudget management
Soft Skills
leadershipcoachingmentoringorganizational skillscommunication skillsteam managementtalent assessmentcontinuous improvementperformance evaluationprioritization
Certifications
Bachelor’s degree in engineeringBachelor’s degree in chemistryBachelor’s degree in biologyrelated technical discipline certification