Technician I, Calibration

Job Title: Technician I Location: Cranbury NJ Job Summary: This is a full-time position, reporting to the Associate Director of Facilities & Engineering. The Metrology Technician will be responsible for operational excellence in calibration management during site build and transitioning into full operations. Working closely with the Metrology team, the technician will have ownership of the calibration processes and methodologies, adherence to regulatory and industry standards, troubleshooting, reliability management, and continuous improvement of the site instruments.

Job Functions:

• Ensure calibration and instrumentation adherence to the site, corporate, and regulatory requirements and safety regulations and act as a 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
• Optimize maintenance/calibration programs for instrumentation and test equipment on site.
• Lead upgrade projects, managing all aspects from concept justification to final commissioning.
• Work closely with and guide entry-level peers, contract staff, and vendors in the execution of daily tasks.
• Maintain operational budgets relating to the calibration and maintenance of process instrumentation, calibration standards, validation test equipment, and QC laboratory equipment.

Qualifications:

• Minimum three years experience as calibration/instrument engineer in the biopharmaceutical/ pharmaceutical industry during sustaining day-to-day operating environment.
• Experience as a calibration/instrument technician responsible for regulatory or client audit readiness and execution.
• Strong communication and presentation skills.
• Excellent organizational 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 various technical and non-technical personnel teams.
• Previous experience with the oversight of site calibration compliance.
• Experience with Computerized Maintenance Management Systems (CMMS), Preferably Maximo.
• Ability to travel within the US is a must.

D esirable:

• Preferably a third-level qualification in Automation or Instrument Technician or Equivalent.
• Minimum of 5 years of 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.
• Write and review calibration SOPs and work instructions
• Ability to create and implement Service Level Agreements (SLAs) with external vendors for calibration activities and parts procurement.
• Experience in the management of QC Laboratory instruments for calibration requirements.
• Leading, Coaching, and facilitation skills.
• An ability to work through peers and across organizational boundaries and at all levels in the business.
• Ability to efficiently use current computer packages, particularly Excel, PowerPoint, MS Project, and Word.

Salary range for this job is 41,000-65,000 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 The job description does not intend to list all the duties and responsibilities assigned to this position. Employees in this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.