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 over 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.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech. We empower career development through in-house training, mentorship, and guidance to facilitate career progression. Our goal is to create high-performing teams that exceed client expectations regarding quality, staying within budget, and meeting timelines.
New Opportunity
We have an exciting opportunity for a Process Engineer to join our site's Process Engineering Group, reporting to the Technical Engineering Manager. This new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing, focusing on automated visual inspection. The ideal candidate will participate in cross-functional or single-function teams, liaising with vendors or above-site groups. Prior related work experience, ideally in manufacturing, preferably GMP settings, is essential.
Requirements
* Design, author, review, approve, and execute qualification/validation documentation and process development studies according to the standard approval process.
* Design, author, review, approve, and execute execution/development of change controls.
* Contribute to Kaizen events as necessary.
* Provide technical input into quality notifications by authoring/reviewing/approving investigations.
* Execute 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 using standard tools and methods to resolve machine and system issues.
* Serve as a technical engineering representative for internal technical group discussions and represent technical operations at global technical forums.
* Drive compliance with global policies, procedures, and guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
* Work collaboratively to drive a safe and compliant culture.
* May be required to perform other duties assigned.
Experience, Knowledge & Skills:
* Demonstrable experience of leading technical-related projects.
* Previous experience with Automated Visual Inspection Systems is desired but not essential.
* Evidence of continuous professional development is desirable.
* 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 necessary.
* Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
* Report, standards, policy writing skills required.
* Equipment and process validation.
* Sterile filling processes and equipment.
* 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.
Qualifications & Education:
* Bachelor's Degree or higher required, ideally in a Science, Engineering, or other Technical discipline.
* Preferably Min 1 year's experience, ideally in manufacturing, preferably GMP Setting.