Senior Process Engineer
4 weeks 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 point 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.
Description:
Process Engineer/Scientist required to work within the Process Development Commercial Support team based in Dublin. The team is responsible for providing process and product support to drug product formulation and fill-finish operations in client site as drug product process SMEs
Requirements
Key responsibilities listed below but primarily the Hiring Manager can foresee support will be needed for the following:
1. Day-to-day operations support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
2. Key contributor to product and process investigations, responsible for assessing product and process impact.
3. Leads continuous improvement projects to improve process performance and productivity.
The chosen candidate would typically be involved in activities such as (but not exclusively);
• Assess product impact associated with proposed changes to commercial processes under the change control process.
• Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation.
• Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support.
• Review and approve changes to operating procedures, electronic batch records, and product documentation.
• Risk assessments and mitigation projects relating to line performance.
• Perform process gap analysis and developing strategies to close gaps.
• Data trend analysis for all performance aspects of the area.
• Troubleshooting performance trends.
The chosen candidate will work collaboratively within the process teams structure and contribute as a member of cross functional teams within the local organization and functional team globally.
Basic Qualifications:
• Bachelor’s or Masters degree in Engineering, Science or related discipline with 6 years experience in a similar role OR PhD and 3 years of directly related experience.
• Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
Preferred Qualifications:
• Typically 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation
• Qualification in Lean and 6-sigma methodologies would be an advantage.
• New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous.
#LI-AP1
Requirements
Key responsibilities listed below but primarily the Hiring Manager can foresee support will be needed for the following: 1. Day-to-day operations support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping. 2. Key contributor to product and process investigations, responsible for assessing product and process impact. 3. Leads continuous improvement projects to improve process performance and productivity. The chosen candidate would typically be involved in activities such as (but not exclusively); • Assess product impact associated with proposed changes to commercial processes under the change control process. • Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation. • Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support. • Review and approve changes to operating procedures, electronic batch records, and product documentation. • Risk assessments and mitigation projects relating to line performance. • Perform process gap analysis and developing strategies to close gaps. • Data trend analysis for all performance aspects of the area. • Troubleshooting performance trends. The chosen candidate will work collaboratively within the process teams structure and contribute as a member of cross functional teams within the local organization and functional team globally. Basic Qualifications: • Bachelor’s or Masters degree in Engineering, Science or related discipline with 6 years experience in a similar role OR PhD and 3 years of directly related experience. • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. Preferred Qualifications: • Typically 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation • Qualification in Lean and 6-sigma methodologies would be an advantage. • New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous. #LI-AP1
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