Metrologist

Job Title

Metrologist

Requisition

JR000012991 Metrologist (Open)

Location

Hobart, NY (Pharma) - USA036

Additional Locations

Hobart, NY

Summary of Position

Position functions as a technical resource in supporting company objectives with respect to calibration programs at the Hobart Facility. Position will expand, develop, maintain and validate the calibration program in the manufacturing, packaging, utility, and laboratory areas, and transition and integrate outside vendor calibrations into the existing calibration program. Position will improve data integrity capabilities by introducing electronic calibration data records and related software.

Position will research, purchase and implement calibration standards, technologies, instrumentation, weights and measures for use with the expansion of the in-house calibration program, which will reduce calibration program costs by eliminating vendor coordination issues, reducing calibration durations and minimizing operations equipment downtime.

As an individual contributor, the position will serve as a subject matter expert (SME) to ensure that all processes are cGMP compliant, satisfy regulatory requirements, and align with current international standards. Position will conduct capability studies, perform internal audits, and ensure calibration records are audit ready. Position will develop calibration methods and techniques based on principles of metrology, the science of weights and measures, including technical analysis of measurement problems to satisfy accuracy and precision requirements.

Position will evaluate and improve calibration procedures, assist with calibration and maintenance of analytical service instruments, provide training for calibration and maintenance technicians, and support site right first time, safety and quality initiatives.

Job Results & Essential Functions

Performance of Functional Area & People Are Appropriate for Business Needs

Staff Aligned to Organizational Goals: Translates the corporate vision, values and goals into day-to-day activities and behaviors; guides and motivates program team and others to take actions that support the vision, values and goals. Performance Managed: Manages program performance by clearly defining standards of performance, by tracking progress against goals, providing clear, thorough, timely feedback; and assisting with addressing performance issues promptly. Develops and identifies coaching opportunities. Provides training and development plans. Provides program with challenging assignments and opportunities to address team development needs. Change Leader: Acts as a champion for change. Encourages team to question established work processes or assumptions; challenges team to ask "why" until underlying cause is discovered; involves stakeholders in continuous improvement actions and alternatives. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities. Resources Allocated to Ensure Critical Priorities Support: Ensures money, technology, and team are allocated to achieve optimal results. Culture of Continuous Learning & Improvement: Anticipates talents, skills and knowledge that will be needed in the program; delegates tasks and responsibilities to the team to grow skills while at the same time managing risk and establishing appropriate controls. Right People Selection & Onboarding: Supports interview process to enable clear selection decisions; assists with onboarding processes. Communication: Creates an atmosphere in which timely and high-quality information flows smoothly up and down, inside and outside of the program; encourages open expression of ideas and opinions.

Essential Functions/Responsibilities

Works with respective operations, laboratory, maintenance and engineering groups in developing and implementing calibrations. Incorporates operations business data (costs, financial, etc.) to generate a compelling project justification and application for funding approval. Performs calibration functions in accordance with accepted practices, and industry and company standards. Develops, reviews, approves and executes commissioning, IQ, OQ, PQ and validation documentation as required in the pharmaceutical environment, while ensuring compliance to all applicable standards related to the technology, including federal, state, and local regulatory codes, as well as operations, engineering, and corporate standards and requirements. Performs advanced troubleshooting on existing calibration equipment. Manages calibrations from conception through completion:

• Interprets equipment capabilities and specifications.
• Supports continuous improvement through process and procedure evaluation.
• Defines equipment required to achieve optimal production.
• Establishes and improves calibration program.
• Manages calibration program improvements, upgrades and modifications.
• Evaluates and troubleshoots calibration equipment.
• Conducts start-up and training.

Investigates equipment performance and identifies any problems for corrective actions and solutions. Works closely with program team to identify issues and implement improvements. Executes Site Acceptance Tests, Commissioning, IOQs and Validation Protocols. Writes and executes Risk Analysis and Calibration Change Control. Utilizes continuous improvement methodology to improve internal processes. Work with reliability personnel to identify and eliminate downtime associated with equipment malfunction.

Asset Center Contains Up-to-Date Site Program Revisions

Writes/revises Calibration SOPs, Equipment Specifications, Qualifications, etc.

Equipment Uptime Maximized Through Resolution of Complex Calibration Problems

Serves as a resource for resolving calibration issues involving safety. Provides calibration support for corrective actions and deviations by identifying root cause and offering solutions. Resolves technical processing issues related to equipment downtime and operation. Position is, at times, hands-on, requiring trouble shooting of complex automated calibration equipment and processes. Acts as a metrology and calibration subject matter expert for equipment operation and efficiencies.

Key Competencies

Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, science, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.

Drives Execution: Coaches, mentors, supports and motivates program team and influences them to take positive action and accountability for their assigned work. Demonstrates effective skill in planning, supervising, monitoring, supporting and accomplishing tasks and calibrations. Knows how to organize programs, teams, activities and processes to get things done efficiently and effectively. Exhibits passion for supporting processes and calibrations, and for achieving success through continuous innovation and calibration execution. Executes tasks and calibrations right the first time, 100% complete and according to program approved procedures.

Project Management: Ability to organize program, team and activities; sees opportunities for synergy and integration where others can't; coordinates the diverse components of projects by quality project planning, execution and change control to achieve the required balance of time, cost and quality; manages projects according to a standard process by using a systems development lifecycle; effectively directs and integrates all aspects of a project or program, ensuring that work progresses toward achieving goals and objectives.

Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answer.

Business case development: Uses financial analysis to evaluate and create strategic choices and options; knowledgeable about how the business and organization work; knowledgeable in current and possible future policies, practices, trends, and information affecting the business and organization; understands the competition; is aware of how tactics work in the marketplace; devises an approach that best positions an idea, plan or activity; leverages supportive factors, breaks through barriers, and addresses the unique needs and preferences of key decision makers.

Technical Learning: Picks up on technical concepts quickly; learns new skills and gains knowledge; learns new industry, company, product, or technical knowledge; does well in technical courses and seminars.

Minimum Requirements

Education:

Bachelor's Degree: Biology, Microbiology or a related Life Science; Chemistry; Chemical, Mechanical, Electrical, Electronics or Pharmaceutical Engineering; Military.

Experience:

Five-Ten Years' Experience: Metrology and Calibration in Pharmaceutical Industry, GMP/GLP Environment and/or other Regulated Industry; ISO/IEC 17025 accredited Calibration Laboratory and/or Military Laboratory; Equipment Repairs, Calibrations, Qualifications, and System Validation.

Military Experience and Training: Precision Measurement Equipment Lab (PMEL); Test, Measurement, & Diagnostic Equipment (TMDE) and/or National Institute of Standards & Technology (NIST).

Preferred Skills/Qualifications:

• Subject Matter Expert for calibration methods and metrology related technologies, and complex calibration equipment.
• Optimize equipment uptime and equipment calibration schedules.
• Evaluate and analyze data to make informed decisions for equipment uptime.
• Improve instrumentation data and standards to support preventative maintenance.
• Perform advanced calibrations on complex pharmaceutical and laboratory equipment.

Other Skills/Competencies:

• Writes and revises advanced calibration procedures.
• Understands accepted metrology and scientific terms, principles and concepts.
• Solves problems where data analysis requires in-depth evaluation of various factors.
• Exercises judgment in the selection of the methods, techniques, and evaluation of criteria to obtain desirable results.
• Develops and improves standard operating procedures, measurement techniques and standards selection.
• Expertise with AutoCAD drawings.
• Experience with calibration equipment used on pharmaceutical manufacturing equipment.
• Experience with FDA, DEA, NFPA, IEEE and OSHA codes and regulations.
• Working knowledge of MS Word, Excel, PowerPoint and MS Project.
• Ability to work both independently and within a team, and able to organize and lead a team.
• Strong organizational skills.
• Strong verbal and written communications skills and ability to communicate clearly and efficiently.

Physical Demands/Work Environment

Physical/Visual Activities or Demands: Physical/visual activities or demands that are commonly associated with the performance of the functions of this job:

Establish Calibration Program and develop Calibration Team to execute calibrations on manufacturing, packaging, utility and laboratory equipment, primarily during normal weekday hours, but sometimes on off hours and weekends, only when operations equipment is available for calibration.

Some light lifting may be required.

Arc Flash Training will be required.

Environmental/Atmospheric Conditions commonly associated with the performance of the functions of this job:

Work is performed in a manufacturing facility, where approximately 60-80% of the time will be spent throughout the facility in the manufacturing, packaging, utility and laboratory areas. The remainder of the time will be spent working in an office environment.