Metrology Supervisor
3 days ago
Sacramento
Job DescriptionJob Title: Metrology Manager Job Description The Metrology Manager provides overall leadership, compliance oversight, and performance management for the metrology function supporting GMP manufacturing, laboratory, and validation environments. This role ensures the effective execution of calibration, maintenance, and temperature mapping programs in alignment with regulatory requirements, internal procedures, and industry standards. The Metrology Manager offers technical leadership, strategic direction, and personnel management to maintain accurate instrumentation, robust data integrity, and continuous improvement of metrology systems. The position serves as the primary interface for cross-functional support, audits, and vendor management. Responsibilities • Own and manage the site-wide metrology program, ensuring full compliance with cGMP, internal procedures, and applicable regulatory standards., • Ensure all calibration, maintenance, and repair activities are executed according to approved procedures and within established timelines., • Maintain a constant state of inspection readiness and actively support internal and external audits related to metrology activities., • Plan, schedule, and oversee the execution of all calibration activities through the CMMS system (such as Blue Mountain)., • Monitor adherence to calibration schedules and proactively address risks that may affect on-time completion of work., • Ensure calibration methods, tolerances, and acceptance criteria are technically sound, scientifically justified, and compliant with regulatory expectations., • Provide advanced technical guidance on complex calibration issues, instrumentation failures, and out-of-tolerance investigations., • Oversee troubleshooting and repair activities for instrumentation, including coordination with original equipment manufacturers and external service providers., • Approve technical decisions that impact instrument reliability, measurement accuracy, and compliance., • Supervise, train, and mentor metrology staff, including assigning workloads and managing performance., • Establish competency requirements for metrology roles and ensure ongoing technical development and training of team members., • Promote a culture of quality, accountability, safety, and continuous improvement within the metrology function., • Review and approve calibration, maintenance, and temperature mapping documentation for accuracy, completeness, and compliance., • Ensure timely initiation, investigation, and closure of Non-Conformance Reports, deviations, and CAPAs related to metrology activities., • Ensure consistent application of data integrity principles (ALCOA+) across all metrology records and systems., • Oversee temperature mapping studies for controlled environments such as warehouses, stability chambers, and incubators., • Ensure temperature mapping protocols, data analysis, and reports meet regulatory and internal quality expectations., • Define and approve sensor placement strategies for continuous monitoring systems to ensure representative and reliable measurements., • Partner with Quality and Operations to support equipment qualification and calibration activities across the site., • Manage vendor relationships for calibration services, equipment repairs, and metrology-related procurement., • Review and approve vendor service reports, ensuring alignment with internal standards and regulatory requirements., • Oversee procurement, control, and storage of calibration standards, ensuring traceability to NIST or equivalent standards., • Develop, track, and report metrology performance metrics, including on-time calibration completion, out-of-tolerance rates, and NCR or deviation trends., • Identify process gaps within metrology workflows and implement improvements to enhance efficiency, compliance, and reliability., • Lead initiatives to improve metrology systems, procedures, and technologies, including optimization of tools and processes., • Support implementation of new instrumentation and automation tools, ensuring proper integration into existing metrology programs., • Drive standardization and best practices across the metrology function to ensure consistency and scalability., • Perform other metrology and validation-related duties as assigned by leadership.Essential Skills, • Bachelor’s degree in Engineering, Science, or a related technical field, or an equivalent combination of education and experience., • Minimum of 5+ years of metrology, calibration, or instrumentation experience in a regulated environment., • Strong knowledge of cGMP requirements and their application to calibration and metrology programs., • In-depth understanding of calibration principles and metrology standards, including USP , USP , NIST traceability, and relevant ISO standards., • Proficiency with computerized maintenance management systems (CMMS), such as Blue Mountain, for planning and tracking calibration activities., • Advanced troubleshooting and analytical skills related to instrumentation and measurement systems., • Demonstrated leadership experience, including the ability to supervise, develop, and motivate technical staff; prior supervisory or leadership experience strongly preferred., • Strong organizational and decision-making skills with the ability to manage multiple priorities in a regulated environment., • Ability to interpret technical data, procedures, and regulatory requirements and translate them into practical metrology practices., • Effective verbal and written communication skills to support cross-functional collaboration and participation in audits., • Strong understanding of data integrity principles and documentation practices, including adherence to ALCOA+ guidelines.Additional Skills & Qualifications, • Experience leading or significantly contributing to site-wide metrology or calibration programs in GMP environments., • Background in supporting validation, equipment qualification, and temperature mapping activities., • Experience working with external calibration vendors and OEMs, including reviewing and approving service reports., • Familiarity with continuous environmental monitoring systems and sensor placement strategies., • Proven ability to develop and track performance metrics and use data to drive continuous improvement., • Experience implementing process improvements, standardization initiatives, or new technologies within metrology or calibration functions.Work Environment This is a full-time, exempt position within a validation-focused environment that supports GMP manufacturing and laboratory operations. The role involves frequent standing and walking throughout production and laboratory areas, with occasional climbing, stooping, kneeling, or crouching to access equipment and instrumentation. The position requires the ability to lift up to 50 pounds occasionally and 25 pounds frequently when handling equipment or calibration standards. Daily work includes extensive use of computers and instrumentation equipment, as well as interaction with CMMS tools and monitoring systems. The role operates in GMP-controlled areas where the use of personal protective equipment, including eye protection, is required, and adherence to gowning requirements and site safety procedures is mandatory. The environment emphasizes quality, compliance, and continuous improvement, with regular collaboration across Quality, Operations, and Validation teams and active participation in internal and external audits. Job Type & Location This is a Permanent position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $100000.00 - $120000.00/yr. Health dental vision 401k Nivagen Pharmacetuicals Workplace Type This is a fully onsite position in Sacramento,CA. Application Deadline This position is anticipated to close on Jun 1, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. 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