3089 Assistant Project Manager I
Responsible for supporting or leading process improvements concerning Maintain Plant, Reliability Engineering, or Facilities Maintenance & Engineering business processes as well as coordinating shutdowns and providing oversight for all aspects of the Facility Fitness program at SSFP.
In addition, the project manager is responsible for addressing compliance gaps and risks by owning Quality records or risk assessments.
The qualified candidate should have excellent communication and project management skills, a passion for Lean continual improvement, and a strong compliance mindset.
Propose and lead business process improvements or changes that will enable efficiencies and/or cost savings Identify the technical, procedural and equipment issues that may compromise production and compliance, working closely with cross-functional groups to identify and implement solutions.
Partner with our colleagues in Facilities & Engineering on equipment design/build projects acting as the Facilities Point of Contact or F&E SME.
Support or lead process improvements or decisions concerning Maintain Plant or Facilities Maintenance & Engineering business processes.
Support or Manage scheduling, coordination, and execution of DP & DS Facility shutdowns within a highly demanding GMP production environment.
Facilitation/coordination of project work and contractors within GMP controlled areas Medium and Large Project Management Establishing all aspects of SSFP’s Facility Fitness program, including but not limited to developing facilities standards and palettes for SSFP Production areas, creating and monitoring Facility Fitness metrics, ensuring compliance with walk-through requirements.
Interact with vendors concerning contracts of considerable financial value and select vendors based on the most appropriate combination of price, quality and delivery.
This often involves negotiations of a complex or controversial nature.
Review and approve vendor information packages, including drawings and/or specifications.
Develops, evaluates and takes action on facilities benchmarking studies.
Make recommendations to senior staff.
Serve as the primary interface with global procurement as necessary to ensure contracts are secured within a required timeframe.
Facilitate issue resolution to ensure compliance with policies and procedures.
Use predictive maintenance technology and software to evaluate signals and make decisions regarding maintenance and/or repairs.
Identify defect patterns and emergent maintenance and/or operational issues.
Track and prioritize resolution of failures.
Review and suggest improvements to existing maintenance strategies, plans, methods and intervals to maximize asset reliability and performance appropriate to equipment criticality.
Address compliance gaps by owning or supporting CAPAs, TACs, and Change records or responding to compliance audits.
Support development of new maintenance strategies by providing input based on site and industry best practices.
Facility Envelope and Utility Inspection Preparedness
Excellent interpersonal and communication skills.
Excellent organizational, planning and project management skills.
Strong mechanical aptitude and troubleshooting abilities.
Willingness to work long hours and weekends as needed.
Working knowledge of cGMP guidelines and compliance within controlled work spaces.
Working knowledge of Pharmaceutical or Biotech Manufacturing processes.
Practical knowledge of Manufacturing Utility systems; water, air, HVAC, oxygen, etc.
Ability to read and interpret engineering documents
Work Environment/Physical Demands/Safety Considerations:
Standard Office environment
BA / BS degree in life sciences or engineering or relevant experience.
2+ years experience in Biochemical Manufacturing preferred.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.