Engineering Project Coordinator
Company: System One
Location: Lansdale
Posted on: May 1, 2024
|
|
Job Description:
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.
System One, and its subsidiaries including Joul--, ALTA IT
Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in
delivering workforce solutions and integrated services across North
America. We help clients get work done more efficiently and
economically, without compromising quality. System One not only
serves as a valued partner for our clients, but we offer eligible
full-time employees health and welfare benefits coverage options
including medical, dental, vision, spending accounts, life
insurance, voluntary plans, as well as participation in a 401(k)
plan.
System One is an Equal Opportunity Employer. All qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex (including pregnancy, childbirth, or
related medical conditions), sexual orientation, gender identity,
age, national origin, disability, family care or medical leave
status, genetic information, veteran status, marital status, or any
other characteristic protected by applicable federal, state, or
local law.
Keywords: System One, Freeport , Engineering Project Coordinator, Engineering , Lansdale, New York
Click
here to apply!
|