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.
Reporting Relationships:
Role that this position reports to: Metrology Engineering Manager
Role/s that report to this position: None
Main Responsibilities and Accountabilities:
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.
Position Qualifications and Experience Requirements:
Education
- 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.
Experience
- 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.
Competencies
- Knowledge of Six Sigma / Lean principles a plus
- Well-developed ability in working with others through a matrix management structure.
- Advanced skills in MS-Project, MS-Excel, MS-Word, MS-PowerPoint, MS-Visio,
Power BI, SAP, and MS-Outlook.
- Understand GxP principles.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
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!
Keywords:
Metrology, Calibration, Engineering, Pharmaceutical Manufacturing, Project Management, Quality Assurance, Safety Standards, Continuous Improvement, Risk Management, Six Sigma
