Description:

Lead and support core site processes by managing Metrology Technicians to ensure timely calibration activities. Collaborate with the Metrology Manager and Engineers to identify improvement areas and troubleshoot issues to minimize downtime. Implement continuous improvement actions in metrology processes to meet compliance, quality, time, and budget goals at the Kankakee site. Foster a culture of continuous improvement by partnering with various stakeholders to innovate, reduce waste, and apply engineering principles within the department. Ensure adherence to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) in all activities, which are vital for the success of the Value Streams.

Responsibilities:

Leadership & Supervision

• Aids in the planning and coordination of various activities to ensure that there is sufficient staffing and coverage at all times. This includes managing schedules, assigning tasks, and confirming that resources are properly allocated to meet operational needs.
• Tasked with enforcing disciplinary measures when necessary, ensuring compliance with established guidelines, and maintaining a respectful environment. This involves assessing situations, documenting incidents, and communicating consequences to those involved as part of upholding standards of behavior.
• Please offer guidance on how to effectively allocate resources, which includes assigning personnel to specific tasks, identifying PMs for oversight, scheduling regular calibrations for accuracy, and determining the necessary equipment for each project to ensure optimal efficiency and productivity.

Metrology & Calibration Management:

• Oversee calibration, verification, and maintenance of all measuring and test
• equipment (M&TE).
• Ensure traceability to national/international standards (e.g., NIST).
• Manage internal and external calibration services.
• Maintain calibration intervals, procedures, and records.

Quality & Compliance:

• Ensure compliance with ISO 9001, ISO 13485, FDA, GMP, or other
• applicable standards.
• Support internal and external audits related to metrology and calibration.
• Investigate measurement-related nonconformances and implement
• corrective actions.

Technical Support:

• Offer in-depth knowledge on various measurement techniques, including their methodologies, principles of uncertainty analysis, and considerations for selecting appropriate gages for specific applications.
• Collaborate closely with the Engineering and Manufacturing teams to validate new equipment and implement process modifications effectively. Ensure that all necessary checks and assessments are conducted to ensure the reliability and efficiency of the updated systems.

Systems & Documentation:

• Maintain calibration management systems (DMMS, SAP, etc.).
• Examine and analyze the SOPs, detailed work instructions, and calibration protocols to ensure they are up to date and effective in guiding operations.
• Make sure to keep everything crystal clear with precise documentation, eye-catching labels, and a clear understanding of equipment status.

Continuous Improvement:

• Identify opportunities to improve measurement accuracy, efficiency, and cost.
• Drive standardization and best practices across departments.
• Support lean, 5S, and continuous improvement initiatives.

Provide a positive, equitable working environment that emphasizes the CSL.

Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior

Performance.

Qualifications and Experience

Education:

Associate's or Bachelor's degree in Engineering, Metrology, Quality,

or related field (or equivalent experience)

Experience:

Experience in Metrology functions within the pharmaceutical industry and/or

plant engineering, machine engineering or process engineering in

pharmaceutical, food or chemical industry is required. Knowledge in plant

maintenance, Metrology / Calibration, and manufacturing processes.

- 5+ years of experience in metrology, calibration, or quality inspection

- 2+ years of supervisory or lead experience

- Strong knowledge of dimensional measurement, GD&T, and inspection techniques

- Experience with MSA, gage R&R, and calibration systems

- Proficient knowledge of Good Manufacturing Practices (GMPs)

- Experienced in acting as a situational leader for internal and external customers.

- Audit and Investigation Skills, Report Writing Skills.

- Ability to develop cohesive presentations

- Strong verbal, technical writing, and interpersonal skills are required.

- Computer Literacy (Microsoft Office applications, Trackwise, SAP, other)

- Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance

documents.

- Knowledge of multiple problem-solving methods (i.e., Six Sigma, Statistical Process Control, Design of

Experiment, Fish Bone

Analysis, 8D, etc.)

Competencies:

- Communicate Effectively - Written and Verbal

- Collaboration

- Instills Trust

- Results Driven - Problem Solving

- Situational Adaptability

- Action Orientated

- Drives Engagement

The expected base salary range for this position at hiring is $93,000 - $110,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.