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Process Engineer NPI
4 months ago
About PSC Biotech
Who we are?
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 of 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 though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview:
New exciting opportunity now exists on our Carlow 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 with a particular focus on automated visual inspection, The ideal candidate 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 appropriate working environments.
Knowledge of process monitoring systems, automation systems, operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial.
- Previous experience with automated visual inspection is desired.
- Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process
- Design/Author/Review/Approve/Execute Execution/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
- Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums
- 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 in Carlow
Requirements
· 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 a necessity
· 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 orientated manner
Qualifications:
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- Preferably Min 2 years experience ideally in manufacturing, preferably GMP Setting
Requirements
What you will do: Bring energy, knowledge, innovation and leadership to carry out the following: Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes. Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. Support implementation and training for site Quality Systems and site GMP readiness activities. Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. Support other QA colleagues, as required. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Support gathering of site metrics Ensure the escalation of risks to management in a timely manner. What skills you will need: In order to excel in this role, you will more than likely have: 5 years’ experience in an FDA / EMA regulated environment, ideally in Quality Assurance, Quality Control, Operations or Technical Operations within the Biological and/or pharmaceutical industry. Previous experience in SAP Master Data build and maintenance QMS development and maintenance. Previous experience in Deviations and Change Control, participating in investigations and problem solving. Strong attention to detail and precision in preparing and reviewing GMP documentation. Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc. or similar Strong written and verbal communication skills. Ability to think logically and be proactive under pressure. Ability to work as part of a team and on own initiative in a constructive manner. Knowledge of major Health Authority Guidelines and Regulations related to Biologics and/or Pharmaceuticals. Desirable: Experience in direct interactions with regulatory agencies during site inspection.
