Senior Project Engineer – Pharmaceutical / GMP Manufacturing

PSC Biotech® Corporation; Leinster; On-site; EUR 65,000 - 95,000; Full time

Job summary

PSC Biotech Corporation in Ireland is seeking a senior Project Engineer to support the commissioning and qualification of a drug substance and drug product facility. You will work within the Global Engineering Team to deliver integrated project engineering services and act as a client representative.

You will lead cross-functional project teams, manage schedules and budgets, and coordinate installation, start-up and OQ/PQ activities.

Qualifications

• Minimum 8 years post-education engineering experience in GMP processing design and start-up.
• Degree in engineering; preferably Chemical Engineering.
• Proven ability to lead projects and work as part of a team.
• Excellent communication, presentation and organizational skills.

Responsibilities

• Preparation of project deliverables such as schedules, work plans and 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 teams to ensure post-OQ readiness (PQ, PPQ).
• Monitor costs/progress and provide status reports to project tiers and stakeholders.
• Support cross-functional teams to reflect stakeholder inputs in design deliverables.
• Liaise with stakeholders, equipment vendors, partners and SMEs across sites to support the project.

Skills

Project engineering

GMP

OQ/PQ

Cross-functional teams

Communication

Education

B.Sc./M.Sc./M.Eng in Engineering

Job description

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, 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.

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, 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 point 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 of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being 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.

Requirements

Job 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 (Preferably Chemical Engineering).
• Process Engineering demonstrated experience.
• Minimum of 8 years post academic engineering experience in relevant GMP processing design and start-up environment.
• Demonstrated ability to be a Project Lead
• Demonstrated ability to be a team player
• Excellent communication/presentation/organizational skills

Additional Information:

• This is a contract position. Estimated assignment duration is approx. 18 months, with initial 12 month contract.
• The position is based fulltime onsite ,the role may require small periods of travel to support vendor reviews. Flexibility is required in this regard.
• Looking for candidates who are willing to work as a LTD