Calibration Manager

Job Title - Calibation Manager

Work Location - Cranbury NJ

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.

Job Summary

This is a full-time position, reporting to the Associate Director of Facilities & Engineering Department. The Calibration Manager will be responsible for operational excellence in calibration management both during site build and transitioning into full operations. Working closely with the calibration technician team, the Calibration Manager will have ownership of the calibration processes and methodologies, adherence to regulatory and industry standards, as well as troubleshooting, reliability management, and continuous improvement of the site instruments.

Job Responsibilities

• Ensure calibration and instrumentation adherence to site, corporate, and regulatory requirements, safety regulations, and act as the point of contact during all internal and external audits.
• Provide expert input for technical instructions, best practices, and standard operating procedures in the execution of calibration principles on-site.
• Act as site calibrations SME for investigations, CAPAs, and change controls as required.
• Develop, maintain, and ensure site adherence to Calibration standards and specifications.
• Develop and sustain an instrument reliability program demonstrating tangible improvement initiatives, reducing instrument-related discrepancies/failures, contributing to cost-saving initiatives, and optimizing maintenance/calibration programs for instrumentation and test equipment on-site.
• Develop and lead upgrade projects, managing all aspects from concept justification to final commissioning realisation.
• Develop, implement, and manage third-party calibration service provider contracts.
• Develop and maintain operational budgets relating to the calibration and maintenance of process instrumentation, calibration standards, validation test equipment, and QC laboratory equipment.
• Assist management in supervising staff, contractors, and contract services providers in the performance of their routine tasks.
  
  
  
  

Qualifications

• Minimum 10 years’ experience as a calibration/instrument manager or engineer in the biopharmaceutical/ pharmaceutical industry during a sustaining/day-to-day operating environment.
• Experience as a calibration/instrument engineer with responsibility for regulatory or client audit readiness and execution.
• Strong communication and presentation skills.
• Excellent organisation skills with the ability to manage own work.
• Strong technical knowledge with demonstration of robust problem solving and continuous improvement.
• Must be able to work with a variety of teams, made up of both technical and non-technical personnel.
• Previous experience in oversight of site calibration compliance.
• Experience with CMMS, preferably Maximo.
• This position requires the manager to perform routine calibrations and troubleshoot instrumentation.
  
  
  
  

Desirable

• Preferably a third-level qualification in Automation, Instrument Engineering, or Equivalent.
• Minimum of 10 years’ experience in a highly regulated environment- biopharmaceutical/ pharmaceutical preferred.
• Experience with a start-up or Greenfield site.
• Experience in leading site-wide instrumentation projects to completion.
• Demonstration of budgeting control and management.
• Ability to create and implement SLA’s with external vendors for calibration activities.
• Experience in the management of QC Laboratory instrumentation for calibration requirements.
• Coaching and facilitation skills.
• An ability to work through peers and across organizational boundaries and influence at all levels in the business.
• Ability to efficiently use current computer packages, in particular Excel, PowerPoint, MS Project, and Word.
  
  
  
  

The anticipated pay for this position is $60,000-125,000

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and the company's business needs.

WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability