Industry Pharma/Biotech/Clinical Research
Work Experience 5+ years
City Dundalk
State/Province Louth
Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in ****, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.
We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
"Take your Career to a new Level"
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry.
We offer a permanent contract of employment giving exposure to working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech.
We provide empowering career development through Learning & Development, in-house training and mentorship, to facilitate career progression.
We believe in creating high performing teams that can exceed our client's expectations with regard to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are met.
Overview
Provide project engineering services in support of the commissioning and qualification of a drug substance and drug product manufacturing facility.
The job-holder works within the Global Engineering Team to act as client representative to deliver integrated project engineering services to meet the Project Objectives.
The Project Engineer will assist in the management of cross functional teams to deliver a portfolio of assigned projects.
Responsibilities
Preparation of project related deliverables such as schedules, work plans, equipment cost tracking
Coordination of project activities between stakeholders
Manage installation/start-up/testing of key equipment systems through OQ completion
Interface with cross-functional team to ensure systems' post-OQ (PQ, PPQ) readiness
Monitor costs and progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders
Support cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables
Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the Network as required to support Project
Education/Experience Requirements
Minimum qualification B.Sc.
or M.Sc.
/ M.Eng Degree in Engineering
Minimum of 6 years post academic engineering experience in relevant aseptic/sterile processing design and start-up environment
Demonstrated ability to be a team player
Notes
This is a contract position.
Estimated assignment duration is approx.
24 months, with initial 12 month contract.
The position is based fulltime onsite at the Site; the role may require small periods of travel to support vendor reviews.
Flexibility is required in this regard.
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