Senior Production Engineer/System Owner-Fill Finish

Role Overview:

Provide leadership and support to meet the maintenance needs of manufacturing specifically compliance, quality, time, and budget. This position supports a culture of continuous improvement by researching, proposing, and implementing measures to drive innovation, reduce wastes, and apply engineering principles/knowledge to continuously improve safety, technical compliance, equipment, and process reliability.

Reporting Structure: Sr. Manager, Maintenance Services per Value Stream
Direct Reports: None

Main Responsibilities and Accountabilities:

• Ensures the development and integration of new equipment or innovative technology. Drives LEAN and continuous improvement initiatives in production and analyze our current manufacturing operations to locate inefficiencies and the elimination of “non-value added” activities.

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

• Proactively implements recommended optimizations and adjustments of production facilities and equipment including self-reliant assurance of GMP compliance (change management, qualification, and validation activities).

• Must spend significant time “on the floor” across all operational shifts.

• Hands-on experience in manufacturing engineering solutions, developing processes, debug, and failure analyses.

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

• Supports the coordination and planning of shutdown activities in regard to equipment and maintenance activities.

• 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, etc. discussions and reviews with consideration of cGMP compliance and Safety.

• Oversees and provides support to Production Engineers in their daily work and maintenance planning for Operations. This work includes, but is not limited to: Maximizes efficiency/OEE (Operational Equipment Effectiveness), yield, output, & capacity of the systems.

• Supports updates to maintenance and calibration plans.

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

• Presents obsolesce of system parts and components that can impact safety, quality, and reliability.

• Develops end-of-life replacement plans for the system to ensure reliable supply to our patients.

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

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

• In the absence of Production Engineers, provides support to Value Streams related to daily business.

• Strictly complies with requirements from CSL Behring’s Safety Program and procedures, including Health and Safety mandates, PPE requirements, and OSHA requirements.

• Responsible to immediately remove hazards and risks where possible by yourself or inform your supervisor as soon as possible.

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

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

Education

• Requires a bachelor’s degree in Mechanical, Chemical or Manufacturing Engineering.

Experience

• Experience in similar 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 and manufacturing processes.

• BS and 6+ yrs of relevant experience or MS and 4+ yrs of relevant experience.

• Proficient knowledge of Good Manufacturing Practices (GMPs).

• Experienced to act as a situational leader for internal and external customers.

• Strong 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

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.