Project Manager – Biopharma Process/Utility Engineering (JP12143)

• Be individually accountable for the verification deliverables on key capital projects
• Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
• Assist in development and review of User Requirements Specifications (URS).
• Suggest design modifications to address risks and design in quality and safety.
• Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).
• Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.
• Recommend, evaluate, and manage performance of contract resources
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout
• Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
• Ensure safety during commissioning, validation, maintenance, and manufacturing activities
• Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed
• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable
• Suggest design modifications to address risks and design in quality and safety
• Develop commission strategy
• Oversee development of validation protocols, Automation System Delivery
• Lead teams
   

• Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.
• Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
• Provide ad hoc technical support and guidance for manufacturing and maintenance
• Assist in developing and project engineering & management metrics
   

• Good Fundamental Leadership and Values
• Good Fundamental Engineering
• Good Fundamental Project Management
• Looking for a PM who will support manufacturing plant/ engineering group

• Bachelor's degree in engineering or another science-related field
• 5 years of relevant work experience with 1 years’ experience in operations/manufacturing environment
• Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment
• Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
• Experience with combination product / medical device quality systems verification
• Process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
• Process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.
• Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
• Demonstrated strong communication and technical writing skills
• Strengths in facilitation and collaboration / networking
• Experience in developing SOPs and delivering training
• Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
• Good record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
• Demonstrated skills in the following areas:
  • Problem solving and applied engineering.
  • Basic technical report writing.
  • Verbal communication.
• Demonstrated Skills in the following areas:
• Basic technical presentations.
• Personal Organization.
• Dealing with and managing change.
• Technical (Equipment Specific).
• Analytical Problem Solving.
• Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS).
• Specialized equipment/process expertise.
• Ability to handle multiple projects at the same time.
• Demonstrated Skills in the following areas:
  • Schedule development
  • Facilitation
  • Collaboration
  • Basic project management
  • Completion and follow-up
• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Demonstrated Skills in the following areas:
  • Negotiation, persuasion, and facilitation collaboration
  • Project cost development
  • Conflict resolution
  • Leadership and team building
  • Schedule and resources loading development
  • Customer service in a technical setting
  • Management of contractors and vendors.
  • Flexibility to work off-hours.

• Poor Leadership: Safety & Quality
• Poor Communication
• Poor Teamwork

Salary : $65 - $75