Senior Process Engineer

3 days ago

Cork, Ireland PSC Biotech Corporation Full time

- Industry: Pharma/Biotech/Clinical Research
- Work Experience: 5+ years
- City: Cork
- State/Province: Cork
- Country: Ireland

Job Description

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 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 unparalleled empowering career development through Learning & Development in-house training mentorship, and constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are met.

Overview:
Provide process engineering services in support of the design and commissioning & qualification of a significant expansion to an existing bulk vaccine processing facility. The job-holder works with the Process Engineering Team as a client owner representative to deliver Project Objectives.

The Senior Process Engineer will manage cross-functional teams to deliver the following scope:

- Equipment package design, factory acceptance testing, installation, and commissioning
- Packages may include Product Vessels, Single Use Mixers, Single Use UFDF skids & CIP/SIP skids.

Department: Technology Center, Global Engineering Solutions (GES)

Position Reports to: Director Engineering

Requirements

Responsibilities:

- Support GES Process Lead to implement a Process Design based on the scope of Process Requirements outlined in the project scope of work.
- Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in C&Q deliverables.
- Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
- Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
- Oversee C&Q progression by a partner firm.
- Ensure Global and engineering standards, procedures, and practices are followed.
- Support GES C&Q Lead to coordinate preparation and, at times, lead C&Q field execution.
- Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
- Manage installation/start-up/testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
- Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the Manufacturing Network as required to support Project.

The job-holder will also undertake Project Engineering duties including:

- Preparation of project-related deliverables such as schedules, work plans, equipment cost tracking
- Coordination of project activities between stakeholders

Education/Experience Requirements:

- Minimum qualification: B.Sc. or M.Sc./M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with the basic elements of chemical/biochemical engineering fundamentals as applied to biotechnology/bioprocessing.
- Minimum of 8 years post-academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
- Demonstrated ability to lead/influence teams in a matrix team environment.
- In-depth understanding of process engineering and technologies pertinent to unit process and utility operations for a bulk vaccine/biologics processing facility.
- Knowledge on the application of single-use technologies.
- Knowledge of DCS/PLC process control platforms and industry SDLC methodology such as Delta V.

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