Manager, Metrology Engineer

Provide leadership and support site core processes by managing & optimizing metrology systems, standards & calibration activities. Collaborate with Metrology Manager and Metrology Engineers to identify areas of opportunities, develop and implement continuous improvement actions related to metrology processes; to ensure Kankakee site needs are consistently met within boundaries of compliance, quality, time, and budget. This position supports a culture of continuous improvement by researching and proposing and (may) implement measures to drive innovation, reduce wastes, and apply engineering principles/knowledge within Metrology department to continuously improve safety, technical compliance, and equipment/process reliability.  Ensure current Good Manufacturing Practices and Standard Operating Procedures are integrated and followed in all activities.  Instrumental to the overall success of the Value Streams by ensuring Metrology equipment reliability.

Role that this position reports to:  Sr. Manager, Operational Engineering Services

Role/s that report to this position: Metrology Engineer

Responsibilities:

1.Works collaboratively with multiple functional areas, Manufacturing, QA, QC Labs, EHS, Process Engineering among others.

• Maximizes efficiency, equipment reliability, yield, output, & capacity of the systems.

• Minimizes quality deviations, OOT's, and waste associated with the systems / Metrology equipment.

• Supports Metrology Engineers to ensure systems and Metrology assets can be operated safely by technicians and Value Stream operators, as applicable.

• Support updates of calibration plans collaborating with the expert groups.

• Practical and administrative coordination between suppliers, EHS departments and production in complicated facility breakdown situations.

2.Aligns with Operational Engineering Services Sr. Manager to provide leadership and support to Metrology Engineers and work closely with Value Streams personnel and Engineering teams to resolve technical issues.  Ensure the technical reliability as well as the safety of production facilities in manufacturing departments. Work with Reliability team to support improvement of equipment reliability and metrics.

• Provides analysis of equipment inspections and failures, developing repair and replacement plans on existing plant equipment.

• Support troubleshooting activities on a daily basis.

• Evaluates and updates Calibration plans to keep equipment performance optimal.

• Implements and monitors predictive maintenance of the system to prevent breakdowns of the system.

• Implements and monitors TPM (Total Productive Maintenance) to ensure the system stays in like-new condition.           

3.Ensures the development and integration of new equipment or innovative technology. Drives LEAN and continuous improvement initiatives and analyze our current manufacturing operations to locate inefficiencies and the elimination of "non-value added" activities related to Metrology assets.

• Conducts studies on engineering proposals to develop designs for process improvements, equipment redesigns, facility improvements and new equipment installation, utilizing and applying engineering principals, research data and proposed project specifications.

• Monitor and support 3rd party vendor service and calibration performance and provide support & Information to negotiate more favorable purchasing agreements.

4.Ensures equipment and processes are compliant with government regulations. Acts as equipment SME during internal or external Regulatory inspections. Recommends and takes corrective action in compliance with quality audits, issues, etc.

5.Proactively implements recommended optimizations and adjustments of Metrology equipment and related systems, including self-reliant assurance of GMP compliance (Change management, qualification, and validation activities)

6.Participates actively and collaboratively as a member of the operations team offering recommendations and ideas where appropriate.

7.Supports Project Delivery department by providing input to all new projects for their department and actively engages in manufacturing, standard work, layout, validation, preventive maintenance, calibration etc. discussions and reviews with consideration of GMP compliance and Safety. 

8.Strictly complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates, PPE requirements, and OSHA requirements. Responsible to immediately remove hazards and risks where possible by yourself and/or engaging EHS department.  Play an active part by supporting our safety goals and play an active part in improving our safety and our safety culture. 

9.Support Metrology engineers on data analysis to identify technical changes and replacement investments based on de-bottlenecking and long-term, obsolescence strategies.

• Prevents obsolesce of Metrology related parts and components that can impact safety, quality, and reliability.

• Oversees reconditioning of the Metrology assets to restore to like-new condition.

• Performs upgrades to improve safety, operational performance, and extend operational life.

• Develops end-of-life replacement plan for Metrology related equipment to ensure reliable supply to our patients.

• Collaborates with local and global partners to develop asset management plan that includes capital requests.

10.Coordination of Metrology Engineer schedule to provide efficient site coverage.

11.Must spend significant time "on the floor" across all operational shifts.

12.Hands-on experience in Metrology Engineering solutions, developing processes, debug, and failure analyses.

13.Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

14.Completes any other duties/responsibilities assigned by senior management.

Qualifications:

• Bachelor's degree in Metrology Engineering, Electrical Engineering or local equivalent preferred.

• 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

• 6+ years of relevant experience and a BS

• 4+ years of relevant experience and a MS.

• Proficient knowledge of Good Manufacturing Practices (GMPs)

• Experienced to act 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.)

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

Our Benefits

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CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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