Project & Master Data Metrology Specialist Job at CSL Behring
CSL Behring in Kankakee, Illinois has grown into a global biotechnology leader, motivated by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. We have recently been awarded America's Best Employers for 2022 by Forbes magazine.
Responsible for developing, evaluating, and implementing cost-effective equipment, facility engineering solutions for a pharmaceutical manufacturing facility. This includes all phases of the expenditures including conception, developing justification, presenting to management, preparation of impact analysis, budget management, project timeline creation and management, detailed design, creating specifications (Design/Functional/System) and vendor/contractor scopes-of-work, competitive bidding, placing purchase orders, open Frontline projects and EAR’s, contractor and consultant supervision, creating and executing change control documentation (GCC’s), performing factory and site acceptance tests (FATs/SATs), installation, commissioning, debugging, optimization, supporting Validation and training maintenance/plant personnel as needed.
This also includes project scheduling, tracking, and resource/ contractor allocation in regard to infrastructure assets, maintenance functions, and repair activities. Interfaces with Manufacturing, Metrology, Utility Services, Validation, QA, QC, R&D, Regulatory and various outside contractors.
Role that this position reports to: Sr. Manager Operations Engineering Services
Role/s that report to this position: None
Responsibilities:
1. Support the planning and execution of plant and capital projects related to Metrology, with input and ownership of capital projects related to Metrology assets.
2. Support shutdown schedule and meetings related to Metrology activities in VS areas.
3. Assist with preparation and management of key Calibrations contracts – M2U.
4. Share formalized continuous improvements based on supporting data, technical knowledge, engineering principles and current industry practices
5. Ability to work with an engineering team and to work effectively in an engineering network.
6. Establishing, tracking, and managing project schedule/critical path activities, status reporting, and resource plan development to ensure projects are completed on time, on-schedule and within budget.
7. Undertake, direct, or assist others in the preparation and approval of Expenditure Proposals relating to Metrology projects and asset repairs. Also ensure, preparation of specifications, and other documentation that comprise the technical requirements for inclusion in bid packages and contracts.
8. Ensure team members understand project objectives, specifications, deliverables, timelines and tasks through ongoing clear, concise communication & motivation of project team members
9. Ensure that risk management methodologies and processes are followed in projects (expense and capital).
10. Identify issues that may delay project deliverables and recommending appropriate risk mitigation strategies, contingencies, and actions to be taken.
11. Reach out to other CSL sites and industry peers to ensure processes, equipment and personnel are Best in Class, (and/or consistent with industry trends).
12. Participate in Regulatory Agency audits.
13. Ensure all contracted contractors comply with all CSL safety standards and ISN program.
14. Collaborate and provide ongoing project updates to senior management and functional leaders to ensure integration and achievement of project milestones.
15. Work closely with site Operations and Quality management to manage and prioritize the production impact as it relates project deliverables and deadlines
16. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
17. Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates, PSM, and OSHA requirements pertaining to Facilities infrastructure assets.
18. Stay current with biopharmaceutical industry best practices and technologies.
19. Completes any other duties/responsibilities assigned by senior management.
20. Maintain SAP Master Data for Metrology Assets to make sure they are in compliance at all times.
Requirements:
- Bachelor’s Degree in Mechanical, Electrical or Chemical Engineering strongly preferred.
- The candidate must have 4+ years of experience in the pharmaceutical industry with extensive project management experience may be considered.
- Excellent knowledge of Metrology equipment maintenance and calibration practices is required
- Must know how to effectively run projects, coordinate contractors, and field the activities.
- A sound understanding of:
Quality management systems and procedures.
Risk management methodology and processes.
Contract management and administration.
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.
About CSL Behring
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.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
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