Project Maintenance Specialist, Bulk

Perform activities related to Facilities expense and capital improvements to assure safe, timely, and
efficient operations of Facilities infrastructure assets.

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. Maintenance Manager / M2U Bulk VS
Role/s that report to this position: None

Responsibilities:
1. Support the planning and execution of plant and capital projects related to facilities infrastructure, with
input and ownership of capital projects related to Facilities assets.
2. Run Summer and Winter shutdown schedule and meetings related to Frac VS areas.
3. Assist with preparation and management of key engineering and supply 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
Facilities projects and asset repairs. Also ensure, preparation of specifications, drawings 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.

Qualifications:
- 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 plant equipment maintenance and a basic understanding of related mechanical equipment 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.
- Knowledge of Six Si