Project Director

PURPOSE

Provides direction, leads, & manages the development & implementation of all FP processes including Assembly & Packaging as part of the overall Site Expansion program in Indiana.

This position will be responsible for building the strategic organization to support the design, build, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) & Qualification of all equipment for FP expansion.

Incumbent will be a key role integrated into the project management & execution team managing strategic expansion projects & will be responsible for full design of FP expansion building & utilities to support the future expansion processes through release & turnover to system owner.

Will lead the work package owners for the areas listed above as well as the technical/engineering team through oversight of an organization comprised of large project team to include CLIENT Full-time Employees & Contractors.

RELATIONSHIPS
Reports to Fill & Finish Expansion Head and serves as a member of the FFEx senior leadership team. Interacts with global counterparts in other FFEx projects as well as with Device Manufacturing Development, Supply Chain, Regulatory Affairs, Quality Assurance.

ESSENTIAL FUNCTIONS
Develop Gate presentations & present all new expansions to management as well as PS management to secure budget for execution of expansion
Develop the organization to support the expansion project ensuring that required resources to execute assembly & packaging lines are staffed
Identify & develop working relationships with affected customers at all levels; ensure that customer representatives are kept appropriately informed of project activities & are encouraged to participate as appropriate
Participate in the expansion management team driving site strategy & solutions for the expansion
Establish the appropriate project governance along with the management team to ensure the project can be executed effectively & the outcome can be sustained in the organization
Advise process teams representing customer needs regarding cross-functional considerations, workflow integration & coordination, & optimization of best practices
Provide & ensure communication with & between project & customer management at critical points in the implementation of the project plan
Ensure that the project is proceeding according to timelines, meeting targets & expectations, & adhering to established operating parameters; negotiate changes in project resources as necessary to achieve objectives & timelines
Design, establish, & maintain an organizational structure & staffing to effectively accomplish the goals & objectives of the project
Recruit, train, oversee, & deploy technical & functional staff
Develop & manage the transition work plans for all project team members, to include transition into the project & back to home departments upon completion
Follow all safety & environmental requirements in the performance of duties
Other accountabilities, as assigned

PHYSICAL REQUIREMENTS
Physical Requirements
Physical Requirement Details Ability to work in an open office environment with the possibility of frequent distraction.
Ability to travel up to 10% of the time.
(% can change on a case-by-case basis based on the role.)

DEVELOPMENT OF PEOPLE
Development of People Supervisory

Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all CLIENT policies, procedures, and culture.
QUALIFICATIONS

• 
  Bachelor s degree in Engineering/Economics/Business Administration from an accredited university required
  Minimum of ten (10) years of proven & successful project management experience required, including:
  Knowledgeable in core work processes & GMP concepts required
  Understanding of complicated product documentation & standard operating procedures with attention to high level concepts required
  Demonstrates functional/business understanding as well as superior written & oral communication skills required
  Extensive knowledge of project management including the ability to create work plans & detailed project schedules.
  Proficient in problem solving, negotiation, conflict management & interpersonal skills required
  Ability to act as project lead & lead cross functional project teams in the development & implementation of projects required
  Ability to influence others on objectives & projects outcomes required
  Basic understanding of contractual documents required
  Ability to read/review design drawings (CAD) with a basic understanding of P&ID s required

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