Pharma Capital Projects Lead Cleanrooms & GMP

Job description:
Responsible for activities in support of capital projects within the Client's network involving ophthalmic drug product manufacturing equipment, utilities, and facility renovations and construction, including but not limited to GMP manufacturing space, labs, and offices associated with aseptic manufacturing.

The successful candidate will work with cross-functional teams to develop integrated schedules and resourcing estimates for individual projects. The role will also involve supporting concept design, detailed design development and planning, but the primary objective will be the project management of the design, building and commissioning of new cleanrooms, utilities and filling line equipment in line with regulatory requirements as defined by FDA and regional Ministries of Health as relevant.
Responsibilities:

• Leadership for new equipment or facility capital investment projects at the Client's Waco, Texas site. Includes capital funding definition, preliminary engineering, detailed design, procurement support, schedule development/timeline management, contractor management and commissioning.
• Direct and lead stakeholders and SMEs through design reviews for facility and manufacturing equipment.
• Deliver capital plan latest best estimates (LBE) as per the established frequency by finance and project accounting.
• Deliver periodic project status reports and gate reviews to project stakeholders and track weekly and monthly project progress in line with agreed schedules.
• Control change during project execution.
• Coordinate and lead shutdown-related activities with all stakeholders.
• Lead final walkdowns of punch lists and engineering turnover packages.
• Become proficient with global engineering standards with particular focus on engineering standards specific to facilities, utilities and equipment.

Education & Experience:

• Degree or diploma in a Science, Engineering, Production or Construction Management discipline.
• Minimum 5 years' experience in pharmaceutical industry and 10+ years in construction management.
• Technical understanding of design drawings including HVAC, clean utilities, black utilities, electrical and process equipment.
• Demonstrated ability to work and communicate effectively with architectural firms, CM teams and main trades in a fast-paced project environment. Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays.
• Previous experience of working in projects of a value greater than $10 Million.
• Ability to control and track change on the project.
• Knowledge of GMP pharmaceutical manufacturing technology and regulatory requirements and familiarity with aseptic manufacturing.
• Good presentation and reporting skills.
• Clear understanding of current legislative, industry and corporate expectations of process and construction safety requirements, with experience in participating in HAZOPs, and in tracking of construction safety metrics.
• Demonstrated ability to complete detailed cost and cash flow tracking for project capital and expense spending against project budgets.
• Demonstrated ability to develop detailed project schedules and track schedule progress during project execution.
• Experience of developing capital funding requests.
• Experience of procurement for equipment vendors and contractors and associated contracts reviews and issues of purchase orders.
• Understanding and experience of supporting process and building equipment commissioning and of pharmaceutical qualification and validation requirements for equipment and facilities.
• Experience of completing final walkdowns, close out of punch lists and handover of contractor turnover packages with vendors and contractors.
• Interpersonal skills to negotiate and reconcile differences.

Top Skills / Requirements:

1. Engineering qualified.
2. Pharmaceutical industry or regulated industry experience.
3. Project management with good communication skills.

Nice to Have:

• Experience in managing packages for Fill Finish and Packaging Equipment.
• Experience in managing large-scale construction fits in the pharmaceutical industry.

Work Environment:

• Group setting.
• Individual setting.
• Combination of both.

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