Process Engineer-NPI
3 weeks ago
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 with 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 being met.
Overview:
As Engineering Specialist, you will lead/execute production floor-based activities, participate in a team of engineers, plan and execute validation activities as required, as well as design and develop engineering studies to support our commercial products.
The team currently consists of engineering professionals working across 4 functions on projects in collaboration with diverse teams across Engineering, Production, and Analytical Labs. 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.
Our Engineers support internal and external manufacturing operations to remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
Requirements
Role Functions:
- Lead/execute production floor-based activities
- Participate in a team of engineers
- Plan and execute validation activities as required
- Design & develop engineering studies
- Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support
- Provide technical input into quality notification by authoring/reviewing/approving investigations
- Execution of equipment/qualification validation programs; including re-qualification and re-validation
- Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
- Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
- Statistical data analysis to support development and commercialisation batches
- Support continuous improvement through Lean Six Sigma methodologies
- Leading and active participation in projects, system failure investigations, and investigation reports
- Execution/development of change controls
- Contribution to Kaizen events as appropriate
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc.
- Implement subsequent corrective action through the change management system
- Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums
- Participate and/or lead cross-functional or single-function teams including liaising with vendors or above-site groups
- Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance
- Work collaboratively to drive a safe and compliant culture
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
- Prior related work experience; ideally in manufacturing, preferably GMP Setting
- Typically have 3 years related work experience in Aseptic manufacturing/process engineering
- Knowledge of regulatory/core 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
- Lean Six Sigma Methodology experience desired
- Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
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