Process Engineer

6 days ago

Tullamore, Uíbh Fhailí, Ireland PSC Biotech Full time
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. We serve over 350 clients in more than 23 countries worldwide, providing cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing, and metrology services.

Employee Value Proposition

We prioritize empowering career development through in-house training and mentorship, aiming to create high-performing teams that exceed client expectations in quality, budget, and timelines.

Overview

We are seeking a Process Engineer for our Carlow site to support new product introduction and commercial manufacturing, reporting to the Technical Engineering Manager. The role involves providing technical support, leading cross-functional teams, and liaising with vendors and site groups. Prior experience in manufacturing, preferably GMP, and knowledge of process monitoring and automation systems are desirable.

Responsibilities

- Design, review, and approve qualification and validation documentation, including process development studies.
- Develop and execute change controls and support continuous improvement initiatives.
- Contribute to Kaizen events and provide technical input into investigations.
- Support equipment qualification, re-qualification, and re-validation programs.
- Perform root cause analysis to resolve system failures and issues.
- Represent technical operations in internal and global forums.
- Ensure compliance with global policies, cGMP, and regulatory requirements, including documentation and audits.
- Promote a safe and compliant work culture.

Skills and Qualifications

- Bachelor's Degree in Science, Engineering, or a related technical field.
- At least 3 years of experience in manufacturing, preferably GMP.
- Proven experience leading technical projects.
- Knowledge of process monitoring, automation systems (DeltaV), and data systems (Pi System) is advantageous.
- Understanding of regulatory standards and equipment validation.
- Proficiency in Microsoft Office and related applications.
- Excellent communication and interpersonal skills.
- Willingness to support hybrid roles and occasional shift work.

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