Job Title: Engineering Project Coordinator

Location: West point, PA

Hours/Schedule: Mon- Fri 8am - 5pm

Type: Contract

Overview

Leading Pharmaceutical Company looking for an experienced professional. Ideal candidates should have at least 2 years of
work experience in the biological/ pharmaceutical/chemical manufacturing industry.

Responsibilities

• Establish and manage project schedules and timelines
• Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts. Stakeholders may include Operations, Quality, Regulatory, Analytical and Process Development functions.
• Responsible for stakeholder engagement, communication, and risk escalation.
• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
• Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.
• Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Consistent application of standardized work, engineering, and process tools (i.e. TrackWise, IPI, MS Project, Excel).
• Provide technical support to manufacturing for problems and issues.
• Work as a team member on complete manufacturing investigations, process improvement and/or validation projects.

Requirements

• Bachelor's Degree in Engineering or Science
• Minimum of two (2) years of work experience in the biological/ pharmaceutical/chemical manufacturing industry
• Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role.
• Minimum of six (6) months' work experience with cGMPs, Change Control, CFR, and other appropriate regulations to vaccine manufacturing.
• Strong understanding of Change Control and Project management
• Demonstrated ability to work both independently and as a part of a team
• Strong technical problem-solving abilities
• Demonstrated effective written and verbal communication skills
• Strong collaboration skills
• Familiarity or experience with aseptic Vaccine Manufacturing Operations or Equipment
• Experience with introduction of process changes to a licensed process

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.