Reference #: JR111951
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 is focused on the planning and execution of projects from estimating to launch:
Manage and communicate the site portfolio of 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 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.
Supervises a staff of engineers and/or engineering technicians and provides guidance, leadership, and mentorship in areas of engineering, project management, and professional development.
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.
Communicates significant equipment or process issues to site leadership.
Measure and analyze performance metrics of the NPI project portfolio, and undertake escalations to address time, cost and scope issues.
Ensure effective communication, planning and coordination between other functions
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.
Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering.
Responsible for the administration, implementation, and project management of assigned projects, including using company-wide standardized methodology.
Coordination of outside design, integration, and equipment manufacturing services.
Manages the site facilities and utilities to accommodate new equipment and meet all regulatory 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 experience in a related industry
College Level Mathematical Skills
Program and Project management
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-LM1
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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.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
