Metrology Associate I

Cook Group; Pittsburgh (Allegheny County); On-site; USD 50,000 - 70,000; Full time

Job summary

Cook MyoSite, Inc. is seeking a Metrology Associate I to support operations by monitoring and controlling laboratory equipment and production related utilities. The role includes calibration, preventive maintenance, and keeping records in the CMMS system.

You will ensure equipment is registered, maintained to defined specs, and that cleanroom and GMP standards are followed. The position is full-time on site in Pittsburgh.

Qualifications

• High school diploma or equivalent with at least 2 years experience with laboratory equipment in a manufacturing facility.
• Minimum of 1-3 years experience in metrology, calibration, or maintenance at a regulated GMP manufacturer.
• Proficient knowledge of Microsoft Office software and other general office equipment.
• Basic understanding of cGMP, 21 CFR Part 11 and related regulations in bio/pharmaceutical manufacturing.

Responsibilities

• Receive, track, and store purchased equipment.
• Perform in-house calibrations and preventive maintenance on lab and industrial equipment using CMMS.
• Notify Metrology Manager of equipment issues and ensure proper labeling and recording.
• Maintain equipment records and ensure compliance with GLP/cGMP guidelines.
• Assist in maintaining preventive maintenance schedules for facilities and utilities.
• Coordinate with vendors to maintain facility and lab equipment.
• Escort and oversee vendors within the facility and manufacturing suite.
• Assist in maintaining equipment procedures and specifications.
• Maintain preventive maintenance schedule for utilities impacting the facility.
• Respond to alarms on monitoring systems and assist in corrective actions.
• Promote GLP/cGMP environment and follow procedures.
• Maintain up-to-date knowledge of lab equipment and usage.
• Support cleanroom operations and participate in cleaning practices.
• Provide on-the-job training to staff for department activities.

Skills

Attention to detail

Microsoft Office

Verbal & written communication

GMP knowledge

Microsoft Office

Education

High school diploma or equivalent

Tools

CMMS

Job description

Overview

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Metrology Associate I assists in supporting company operations by monitoring and controlling laboratory equipment and production related utilities, as well as assist with facility related aspects of equipment and the quality system.

Responsibilities

• Perform the proper receiving, tracking and storing of purchased equipment
• Perform in-house calibrations and preventive maintenance activities including general-purpose test equipment, industrial equipment and laboratory equipment utilizing the site computerized maintenance management system (CMMS).
• Responsible for notifying Metrology Manager and System Owners of any equipment issues
• Ensure that all measuring and test equipment used is registered, assigned and marked with a unique internal equipment number for identification
• Organize files and maintain all laboratory equipment records
• Ensure vendors maintain the facility and laboratory equipment as it relates to the specific service being provided
• Escort and oversee vendors throughout the facility and in the manufacturing suite
• Assist in maintaining all equipment procedures and specifications
• Provide assistance in the organization and maintaining a preventive maintenance schedule for utilities that impact the facility and assist in monitoring alert systems to ensure facilities and equipment operates within defined specifications
• Respond to alarms for equipment on monitoring alert system
• Promotes GLP/cGMP environment and follows procedural guidelines
• Understand and maintain up-to-date knowledge of lab equipment
• Support in maintaining cleanroom environment below alert limits by participating in and following established cleaning practices
• Provide OJT training to applicable staff for all department activities

• Exemplifies Cook MyoSite Core Values
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards
• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Trainability
• Must have effective verbal, written and interpersonal skills

Full Time On Site

Qualifications

High school diploma or equivalent with at least 2 years previous experience with laboratory equipment in a manufacturing facility.

Minimum of 1-3 years' experience in metrology, calibration, or maintenance at a regulated GMP manufacturer.

Proficient knowledge of Microsoft Office software, and other general office equipment.

Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing.

Physical Requirements

• Maintenance Setting (EQ, FA, Safety, Warehouse, MC): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.
• Ability to spend majority of day standing in warehouse setting for extended periods of time, and at times work within confined areas.
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
• Must be able to lift/push/pull up to 50 pounds on a regular basis.
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), appropriate shoes, and facial mask (if required) on a regular basis.

Employee that does not interact with Healthcare Professionals Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace. This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.