Engineering Project Coordinator - Lansdale Pennsylvania

Company: System One
Location: Lansdale, Pennsylvania
Posted On: 05/02/2024

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. More...

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