Metrology Engineer II, Site Services

Roche•South San Francisco, CA

12d

About The Position

Are you a skilled professional with a passion for precision, innovation, and collaboration? We are seeking a dedicated and experienced individual to join our team as a Metrology Leader. In this dynamic role, you’ll be instrumental in ensuring the accuracy and reliability of our calibration processes, managing state-of-the-art metrology laboratories, and fostering collaboration across departments to uphold the highest standards of quality and compliance. If you thrive in environments that challenge your technical expertise, offer opportunities for leadership, and require a strong commitment to excellence, this position is your chance to make a significant impact and help shape the future of our organization.

Requirements

Bachelor degree in Electrical engineering, mechanical engineering (or other science related field) - AA/AS Degree in a related science or engineering major with 10 years’ experience as an instrument or electronics technician or equivalent experience desired - 10 years in manufacturing process instrumentation and control and/or analytical instrumentation or a closely related job or equivalent experience desired - completion of an Instrumentation or Industrial Electronics (2-year) curriculum at a technical school with 10 years’ experience as an instrument or electronics technician.
10 years Metrology or Instrumentation Lab Management experience
Ability to read and interpret P&IDs, engineering documents and schematics.
High familiarity with the disciplines within the International System of Units (SI Units)
Thorough knowledge of the fundamental operating principles of industrial process instrumentation and systems.
Experience with calibration processes and technical spare parts management.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
Computer skill level is appropriate to navigate and use corporate intranet and related applications, CMMS/CCMS, Microsoft and Google Suite programs.
Ability to lift up to 25 pounds.
Ability to distinguish colors.
Working with/around various chemicals (i.e. acids and bases), solvents, pressurized systems, compressed gases, and biological materials (Recombinant DNA).
Work in environments that may include low, medium, or high voltages.
Work in an environment that may include extreme temperatures.

Responsibilities

Ensure all Calibrations completed on Standards are traceable to NIST and International unit of measurement.
Develop and evaluate metrology internal calibrations of Standards that measure characteristics of GMP equipment, substances and tools. Identify the magnitude of error sources contributing to the uncertainty of results to determine reliability of measurement process in quantitative terms.
Maintain all laboratory equipment requirements, authorize equipment purchases, and oversee installation to ensure seamless integration for all SSF Metrology Laboratories.
Ensure adequate quantities of equipment, parts, and supplies are available for daily laboratory operations.
Conduct routine lab safety inspections and audits to proactively identify and mitigate potential hazards.
Foster cross-functional collaboration with EHS, instrumentation, facilities and IT departments to address Metrology lab issues.
Facilitate negotiations and oversee the administration of equipment service contracts and warranties.
Provide/oversee Lifecycle management (e.g. Calibration, Maintenance, and Repair) for Metrology Standards in adherence with Roche cGMP/GLP policies, procedures and processes.
Conduct thorough cost-benefit analyses for aging and damaged Standards to inform decision-making and resource allocation.
Ensure the accuracy of Metrology master data in the Computerized Maintenance Management System (CMMS).
Represent Metrology, locally and globally, on multidisciplinary project teams, presenting data and responding to inquiries to improve customer service, to provide technical data, and assist in determining best practices and align processes.
Drive technical capabilities of cross-campus instrumentation teams, ensuring capabilities and training are adequate.
Prepare and organize technical documentation including, but not limited to: operational and maintenance procedures, investigation reports, unplanned event response; and corrective and/or preventative actions.
Actively involved in completion of GMP records, including Quality Events (QE) investigations, response, and preventative/corrective actions.
Performs diagnostics, calibration/maintenance of Standards, ensuring regulatory compliance.
Create and maintain local standard operating procedures, work instructions and maintenance strategies. Manage the periodic review assessment and execution of procedure revisions.
Define and configure Master Inspection Characteristics (MICs) in SAP QM for various materials, components, and processes.
Collaborate with Instrumentation, Quality Assurance and Master Data teams to understand inspection requirements and translate them into effective MICs.
Establish appropriate inspection methods, sampling procedures, and acceptance criteria for qualitative and quantitative MICs.
Develop and maintain inspection plans and routings in SAP QM, linking them to relevant MICs.
Provide technical support and training to users on SAP QM functionalities related to MICs and inspection processes.
Perform regular audits of MIC configurations to ensure accuracy, compliance, and optimization.
Troubleshoot and resolve issues related to MICs and inspection data in SAP QM.
Participate in continuous improvement initiatives related to quality management processes and systems.
Provide Subject Matter Expert (SME) support for Reverse Traceability process, including on-the-job training, technical guidance, and oversight of business process flow.
Ensure that all relevant Standard Operating Procedures (SOPs) and operating parameters are followed and maintenance activities are properly documented utilizing Good Documentation Practices (GDP).
Support internal and external regulatory inspection.
Review Change Requests, assessing impact on equipment maintenance activities, spare parts availability.