Indivior
Metrology Specialist
Indivior, Raleigh, North Carolina, United States, 27601
TITLE:Metrology SpecialistReports To:
Maintenance ManagerLocation:
RaleighIndivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear.POSITION SUMMARY:The Metrology Specialist will improve & support the safe & effective completion of calibrations. They will support troubleshooting, problem-solving & project implementation for measuring equipment site-wide and ensure compliance with cGMPs as well as local & corporate requirements for calibration compliance.ESSENTIAL FUNCTIONS:The responsibilities of this role include, but are not limited to, the following:Advanced Calibration Accountabilities:
Leads, conducts & participates in systematic problem solving. Supports cross-functional investigations in all customer areas.Evaluates measuring equipment performance & effectiveness of tasks & frequencies. Responds to potential issues.Provides coaching & support to metrology technicians & process owners for measuring equipment.Accurately performs complex mathematical formulas relating to calibrations.Writes procedures & SOPs for performing calibrations & repairs on measuring equipment in the production & utility areas.Designs/Redesigns/Evaluates/Optimizes metrology systems & equipment.Supports and/or executes engineering studies & qualification testing for measuring equipment.Performs complex calibrations in the areas of temperature, pressure, conductivity, humidity, pH, TOC, flow, mass & frequency.Maintains critical metrology standards, equipment & tools.Attains & maintains required site operation & safety certifications. Maintains training qualifications on time.
Planning & Quality Accountabilities:
Supports management & planning department in planning for completion of calibrations.Reviews & approves calibration documentation for accuracy & completeness.Identifies & handles deviations & failure investigations per proper procedures. Supports process owners & Quality personnel in investigations.
Standardization & Continuous Improvement Accountabilities:
Develops work packages & creates plans to support metrology technicians to include required documents, parts & specialized tools or equipment.Leads calibration activities as scheduled, supported by the Supervisor. Prioritizes & leads unplanned calibration activities based on business need.Process confirms calibration activities are performed per standards.Supports Metrology Specialists in developing new or improved calibration methods & procedures.Ensures team members are trained to the standard.Other Accountabilities:Addresses safety, quality, staffing, or personnel issues & escalates to Supervisor if necessary.Owns KPI’s or contributes to KPI reporting.
Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identify opportunities for improvement and make constructive suggestions for change to improve process effectiveness to heighten quality.MINIMUM QUALIFICATIONS:Associates Degree in relevant field or equivalent military or industrial training which includes a thorough understanding of calibration, instrumentation & control systems.Proficiency in the following areas: Metrology, Calibration, Instrumentation & Controls, Electro-Mechanical systems & Electronics.Calibration of process & utility instrumentation & calibration field standards.Experience using electronic calibration management systems such as Calman, SAP, Blue Mountain RAM, ProCal, MAXIMO, etc.Able to read & apply schematics, wiring diagrams & other technical documents.Computer literate with working knowledge of Microsoft Office applications.Documents problems thoroughly & accurately & brings them rapidly to solution.5-10 years relevant metrology/calibration work experience in pharmaceutical or other highly regulated industries, strongly preferred.COMPETENCIES/CONDUCT:In addition to the minimum qualifications, the employee will demonstrate:A high level of organization in task management.Logical planning for task execution & follow-up.A systematic approach to problem solving & troubleshooting.PHYSICAL AND OTHER REQUIREMENTS:Able to move equipment and/or supplies weighing up to 50 pounds within the facility.Able to routinely operate & inspect manufacturing equipment using hands.Able to be on feet for up to a 10-hour shift.Able to transfer materials within manufacturing environment. Frequently moves about the building to access other personnel & operational areas.Corrected Vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license.Able to ascend/descend a ladder to service equipment. Works atop elevated positions at heights.Able to work within confined spaces for inspection, repair & maintenance of equipment.Able to work in loud noise environments with hearing protection.BENEFITS:Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:3 weeks’ vacation plus floating holidays and sick leave.401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay.U.S. Employee Stock Purchase Plan- 15% Discount.Comprehensive Medical, Dental, Vision, Life and Disability coverage.Health and Dependent Care Flex Spending options.Adoption assistance.Tuition reimbursement.Leverage Concierge/personal assistance services.Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage.Gym, fitness facility and cell phone discounts.Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.GUIDING PRINCIPLES:Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.COMPLIANCE OBLIGATIONS:Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:Employee Obligations:Always act with honesty and integrity.Risk IQ: Know what policies apply to your role and function and adhere to them.Speak Up: If you see something, say something.Manager Obligations:Always act with honesty and integrity.Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.Model and reinforce a Speak Up culture on your team.The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.EQUAL EMPLOYMENT OPPORTUNITYEOE/Minorities/Females/Vet/Disabled
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Maintenance ManagerLocation:
RaleighIndivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear.POSITION SUMMARY:The Metrology Specialist will improve & support the safe & effective completion of calibrations. They will support troubleshooting, problem-solving & project implementation for measuring equipment site-wide and ensure compliance with cGMPs as well as local & corporate requirements for calibration compliance.ESSENTIAL FUNCTIONS:The responsibilities of this role include, but are not limited to, the following:Advanced Calibration Accountabilities:
Leads, conducts & participates in systematic problem solving. Supports cross-functional investigations in all customer areas.Evaluates measuring equipment performance & effectiveness of tasks & frequencies. Responds to potential issues.Provides coaching & support to metrology technicians & process owners for measuring equipment.Accurately performs complex mathematical formulas relating to calibrations.Writes procedures & SOPs for performing calibrations & repairs on measuring equipment in the production & utility areas.Designs/Redesigns/Evaluates/Optimizes metrology systems & equipment.Supports and/or executes engineering studies & qualification testing for measuring equipment.Performs complex calibrations in the areas of temperature, pressure, conductivity, humidity, pH, TOC, flow, mass & frequency.Maintains critical metrology standards, equipment & tools.Attains & maintains required site operation & safety certifications. Maintains training qualifications on time.
Planning & Quality Accountabilities:
Supports management & planning department in planning for completion of calibrations.Reviews & approves calibration documentation for accuracy & completeness.Identifies & handles deviations & failure investigations per proper procedures. Supports process owners & Quality personnel in investigations.
Standardization & Continuous Improvement Accountabilities:
Develops work packages & creates plans to support metrology technicians to include required documents, parts & specialized tools or equipment.Leads calibration activities as scheduled, supported by the Supervisor. Prioritizes & leads unplanned calibration activities based on business need.Process confirms calibration activities are performed per standards.Supports Metrology Specialists in developing new or improved calibration methods & procedures.Ensures team members are trained to the standard.Other Accountabilities:Addresses safety, quality, staffing, or personnel issues & escalates to Supervisor if necessary.Owns KPI’s or contributes to KPI reporting.
Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identify opportunities for improvement and make constructive suggestions for change to improve process effectiveness to heighten quality.MINIMUM QUALIFICATIONS:Associates Degree in relevant field or equivalent military or industrial training which includes a thorough understanding of calibration, instrumentation & control systems.Proficiency in the following areas: Metrology, Calibration, Instrumentation & Controls, Electro-Mechanical systems & Electronics.Calibration of process & utility instrumentation & calibration field standards.Experience using electronic calibration management systems such as Calman, SAP, Blue Mountain RAM, ProCal, MAXIMO, etc.Able to read & apply schematics, wiring diagrams & other technical documents.Computer literate with working knowledge of Microsoft Office applications.Documents problems thoroughly & accurately & brings them rapidly to solution.5-10 years relevant metrology/calibration work experience in pharmaceutical or other highly regulated industries, strongly preferred.COMPETENCIES/CONDUCT:In addition to the minimum qualifications, the employee will demonstrate:A high level of organization in task management.Logical planning for task execution & follow-up.A systematic approach to problem solving & troubleshooting.PHYSICAL AND OTHER REQUIREMENTS:Able to move equipment and/or supplies weighing up to 50 pounds within the facility.Able to routinely operate & inspect manufacturing equipment using hands.Able to be on feet for up to a 10-hour shift.Able to transfer materials within manufacturing environment. Frequently moves about the building to access other personnel & operational areas.Corrected Vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license.Able to ascend/descend a ladder to service equipment. Works atop elevated positions at heights.Able to work within confined spaces for inspection, repair & maintenance of equipment.Able to work in loud noise environments with hearing protection.BENEFITS:Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:3 weeks’ vacation plus floating holidays and sick leave.401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay.U.S. Employee Stock Purchase Plan- 15% Discount.Comprehensive Medical, Dental, Vision, Life and Disability coverage.Health and Dependent Care Flex Spending options.Adoption assistance.Tuition reimbursement.Leverage Concierge/personal assistance services.Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage.Gym, fitness facility and cell phone discounts.Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.GUIDING PRINCIPLES:Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.COMPLIANCE OBLIGATIONS:Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:Employee Obligations:Always act with honesty and integrity.Risk IQ: Know what policies apply to your role and function and adhere to them.Speak Up: If you see something, say something.Manager Obligations:Always act with honesty and integrity.Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.Model and reinforce a Speak Up culture on your team.The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.EQUAL EMPLOYMENT OPPORTUNITYEOE/Minorities/Females/Vet/Disabled
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