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AI Summary
GENERAL SUMMARY
Manages engineering projects associated with all domestic company sites by coordinating the complete project lifecycle: definition, design, procurement, construction, commissioning, validation and handover. This includes leading project requirements analysis, scope development/consensus, proposal presentation, design development, placement of contracts, and management of contractors, scheduling/tasking of internal resources, control of project schedules, budgets, and issues management.
REPORTING RELATIONSHIP
Reports To: Director, Engineering Services
Direct Reports: Manager, Project Management
RESPONSIBILITIES
Process Analysis & Project Definition
Achieves project scope and definition agreement from department managers to internal subject matter experts and other resources as required for each project.
Facilitates project requirement analysis workshops to determine the scope of each project. Develops user requirement specifications as required. Coordinates approval by relevant company departments.
Facilitates definition of requirements for complex equipment (e.g. lab sample handling and testing equipment) and IT systems as required. Facilitates completion of investigative studies for complex equipment and functional descriptions for IT systems.
Facilitates further design definition with internal staff to determine the required activities in each work area: space requirements, equipment requirements, utilities requirements, material and work flow diagrams, space adjacencies, etc.
Oversees architectural and engineering work to develop preliminary floor plans and other preliminary design details. Coordinates approval by relevant company departments.
Formulates preliminary project implementation plans and determines project budgets and schedules.
Facilitates development of project justification with input from project sponsors.
Develops Capital Expenditure Proposals and presents to senior management for approval.
Project Coordination and Management
Mobilized and coordinates internal resources against project schedules
Oversees architectural and engineering work on design development, including development of all construction drawings and related engineering documentation. Reviews and approves drawings and documentation. Coordinates approval by relevant company departments
Coordinates and facilitates the preparation of tender documentation for construction contractors and leads the contractor selection process
Develops or assists with development of Request for Proposal (RFP) documentation for equipment to be purchased by the company
Oversees order of company equipment. Arranges for Quality Assurance (QA) to conduct vendor pre-qualification audits for specialized equipment.
Oversees the work of contractors during construction and commissioning to ensure that time, quality and cost requirements are met. Addresses issues as required.
Oversees validation activities including development, approval and execution of validation plans and protocols
Oversees raising of purchase orders and approval of invoices are required
Monitors & reports progress, quality and cost parameters of all projects
Operations & Maintenance Support
Ensures that operations staff is aware of operational and maintenance requirements for new equipment, providing formal handover documentation as required. Works with internal staff to ensure timely and satisfactory resolution of any issues.
Facilitates project teams consisting of both internal company domestic staff and external contractors (architects, engineers, construction firms etc.).
Ensures that finished projects satisfy the requirements of the business and comply with FDA (Food and Drug Administration), GHA (German Health Authority) and other regulatory agency requirements.
Other job-related occasional duties such as assigned.
JOB SPECIFICATIONS
Education
BA degree in Engineering. Mechanical, Industrial, Chemical disciplines or related field or an equivalent combination of relevant work experience and education required equaling up to a minimum of ten (10) years’ experience
Experience
Minimum of five (5) years’ experience in project management, including design, construction, commissioning and validation of facilities and systems in a Life Sciences Industry environment required
Working Conditions
Understands complex problems to collaborate and explore alternative solutions
Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations
Ability to make decisions which have significant impact on the immediate work unit and monitor impact outside immediate work unit
Overnight travel required up to 80% of the time
Fast paced environment with frequent interruptions
About CSL Plasma
CSL Plasma operates one of the world’s largest and most sophisticated plasma donation networks, with nearly 330 donation centers in the U.S. and Europe. CSL Plasma is a subsidiary of CSL, a global biopharma company. Plasma collected at CSL Plasma facilities is used by CSL for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 29,000+ people.
Learn more about CSL Plasma here https://www.cslplasma.com/ and CSL, CSL Behring, CSL Seqirus and CSL Vifor here https://www.csl.com/.
Learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor here at https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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