About PSC Biotech
PSC Biotech is a leading biotech consultancy founded in 1996, headquartered in Pomona, California, with global operations in Ireland, India, Singapore, Australia, and the US. We serve over 350 clients across more than 23 countries, providing cloud-based software solutions for quality management and regulatory inspections, pharmaceuticals contract manufacturing, and metrology services.
Take your career to a new level
We disrupt the conventional consultancy model by offering an employee value proposition that includes working with talented professionals in the pharma/biotech industry. We provide permanent employment contracts, offering exposure to top pharmaceutical client sites in diverse cultural settings.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech. We foster career development through in-house training, mentorship, and guidance to facilitate growth. Our goal is to create high-performing teams that exceed client expectations in quality, stay within budget, and meet deadlines.
Overview
We are excited to announce an opportunity at our Carlow site for a Process Engineer to join the Process Engineering Group, reporting to the Technical Engineering Manager.
The successful candidate will provide technical support for new product introduction and commercial manufacturing, participate in cross-functional teams, and liaise with vendors and other site groups. Prior experience in manufacturing, preferably in a GMP setting, and technology transfer experience are desirable. Knowledge of process monitoring systems, automation (DeltaV), and data systems (Pi System) is beneficial but not mandatory.
Our engineers support manufacturing operations, drive continuous improvement, and have opportunities across diverse areas including biological, chemical, automation, capital projects, maintenance, safety, process development, technical services, utilities, and validation.
Responsibilities
* Design, review, approve, and execute qualification, validation documentation, and process development studies.
* Develop and review change controls.
* Contribute to Kaizen events.
* Provide technical input into quality investigations.
* Execute equipment qualification and validation programs, including re-qualification and re-validation.
* Support continuous improvement initiatives using Lean Six Sigma methodologies.
* Conduct root cause analysis to resolve system failures and performance issues.
* Represent technical operations in internal discussions and global forums.
* Ensure compliance with global policies, procedures, regulatory requirements, and cGMP standards.
* Promote a safe and compliant culture within the team.
* Perform other duties as assigned.
Skills Required
* Bachelor’s degree or higher in Science, Engineering, or a technical field.
* Minimum 3 years of manufacturing experience, preferably in GMP settings.
* Experience leading technical projects.
* Continuous professional development is a plus.
* Knowledge of process monitoring, automation systems (DeltaV), and data systems (Pi System) is desirable.
* Understanding of regulatory and international codes and standards.
* Experience with report writing, standards, and policies.
* Knowledge of equipment and process validation, sterile filling processes and equipment.
* Proficiency in Microsoft Office and related applications.
* Excellent communication, presentation, and interpersonal skills.
* Hybrid role with occasional shift support after training.
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