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Location

Rockford, IL | United States

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Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:
The main responsibilities of the Director - NPI Engineering for drug-device combination products are focused on the planning and execution of projects from estimating to launch:

• Manage and communicate the site portfolio of drug-device combination product NPI projects, ensuring projects are managed to intended capital and resource cost and scope
• Provide resources and oversight to project estimating activities to develop a trusted project resource plan
• Own the resource planning process for the NPI engineering team, coordinated with other functional leaders (quality, validation, facilities, etc.) providing resources to project teams.
• Provide support to project teams, taking on risk mitigations, issue resolution, and escalations to ensure on-time launches at target quality and unit cost
• Leading change and continuous improvement activities for the drug-device combination products NPI process
• Primary Key Performance Indicators (KPI) are On Time Equipment Commissioning and Product Launch; Project Cost Performance; Product Launch Quality and Cost Target Achievement

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Oversees NPI engineering project management for drug-device combination products.
• Supervises a staff of engineers and/or engineering technicians.
• Prioritizes and guides engineering and project management resources in the design of new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to business plan.
• Plan and manage capital plan for facility and production equipment related spending to assure production can meet new product development, equipment commissioning, product launch, and contract packaging requirements.
• Works with global engineering to guide the specification and selection of manufacturing equipment/utility equipment and awards architectural and engineering contracts based on competitive bids and analysis developed by site Project Managers.
• Adapts NPI engineering organization to meet changing product portfolio and customer demands through appropriate hiring and organizational structuring.
• Participates as a member in various steering committees to guide and influence the company's focus on new products, new customers, and strategic initiatives.
• Provides guidance, leadership, and mentorship to staff in areas of engineering, project management, and professional development.
• Communicates significant equipment or process issues to site leadership.
• Prepares monthly reports to company management detailing the status of open projects that support the capacity, regulatory and process improvement requirements of the plant. (Business Unit Review)
• Measure and analyze performance metrics of the NPI project portfolio, and undertake escalations to address time, cost and scope issues.
• Oversees the career and leadership development of the department engineers and technicians.
• Ensure effective communication, planning and coordination between other functions Keeps abreast of technological developments relating to engineering, project management, and combination product manufacturing technologies.
• Provide technical leadership/coaching to the engineering team Responsible for the administration, implementation, and project management of new business, including conformance with customer requirements and equipment / process performance criteria.
• Prepares equipment/engineering estimates for potential projects (to be submitted to sales).
• Analyzes sales requests to determine equipment, tooling, or delivery systems needed.
• Oversee the Engineering review of all components for new jobs (size, capability of equipment, bar codes).
• Conducts and/or participates in customer meetings and attends occasional off-site meetings.
• Interacts with Sales and customers to determine requirements for new products/orders.
• Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering. Management of the Equipment Acquisition and Installation Process.
• Responsible for the administration, implementation, and project management of assigned projects, including using company-wide standardized methodology.
• Researches new trends and technologies in assembly and packaging; evaluates and tests new equipment and processes.
• Coordination of outside design, integration, and equipment manufacturing services.
• Work with staff on development of new equipment performance requirements.
• This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:

• Bachelor's Degree in Engineering or related field
• 7-10 years related experience and/or training.
• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
• High standard of report writing.

Preferred:

• Ability to adapt to changing work environments.
• Ability to effectively present information to various people as the job requires.
• Ability to work independently and/or as part of a team.
• Ability to display excellent time management skills.
• Lean/Six Sigma training
• GAMP5 experience with drug-device assembly processes

#LI-LMI

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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