Process Engineer

Job Description

About PSC Biotech 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. Role Description:

• Process Engineer - Tech Transfer / NPI
• Hybrid – Day’s role with expectation to support shift intermittently when Floor activities/studies are ongoing.
• New exciting opportunity now exists on our Client Site for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager.
• Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross-functional or single function teams including liaising with vendors or above site groups.
• You will typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but we will consider applicants from other working environments as long as they have technology transfer experience.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity for this role.
• Our Engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate.

Requirements

Role Functions:

• Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process.
• Design/Author/Review/Approve/Execute development of change controls.
• Contribution to Kaizen events as appropriate.
• Technical input into quality notification by authoring/reviewing/approving investigations.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation.
• Support continuous improvement through Lean Six Sigma methodologies.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP).
• Work collaboratively to drive a safe and compliant culture.
• May be required to perform other duties as assigned.

Experience, Knowledge & Skills:

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• Min 3 years’ experience ideally in manufacturing, preferably GMP Setting.
• Demonstrable experience of leading technical related projects.
• Evidence of continuous professional development is desirable.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Proficiency in Microsoft Office and job-related computer applications required.
• Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.

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