Process Engineer
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Job Description
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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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.
Job Title: Process Engineer
Process Engineer/Scientist required to work within the Process Development Commercial team. The team is responsible for providing process and product support to drug product vial & prefilled syringe manufacturing in client site.
Requirements
Key responsibilities listed below but primarily the Hiring Manager can foresee support will be needed for the following:
Continuous improvement projects for drug product formulation multiple vial & prefilled syringe filling lines and vial capping lines.
Product and process investigation support.
Responsibilities include:
The chosen candidate would typically be involved in activities such as (but not exclusively):
Definition and scoping of all process improvement activities relating to the area.
Leading continuous improvement programs and productivity initiatives.
Product impact assessments associated with process deviations.
Risk assessments and mitigation projects relating to line performance.
Performing process gap analysis and developing strategies to close gaps.
Data trend analysis for all performance aspects of the area.
Troubleshooting performance trends.
Working with the operational excellence group in implementing OE methods mentoring project leads and facilitating process improvement teams.
Review and approval of changes to operating procedures and the change control process relating to the manufacturing lines.
Supporting new product introduction teams as a process subject matter expert.
Works in a collaborative manner within the process teams structure and contributes to investigations cross functional teams within the organization etc.
Basic Qualifications:
Bachelor s degree in engineering Science or related discipline.
Demonstrated leadership skills with the ability to build teams and operate across functional boundaries both internal and external.
Significant relevant industrial project experience.
Preferred Qualifications:
Typically 35 years engineering experience in a manufacturing environment
Qualification in Lean and 6sigma methodologies would be an advantage.
New product introduction or process improvement experience in a GMP environment would be advantageous.
#LIAP1
Key responsibilities listed below but primarily the Hiring Manager can foresee support will be needed for the following: Continuous improvement projects for drug product formulation, multiple vial & pre-filled syringe filling lines and vial capping lines. Product and process investigation support. Responsibilities include: The chosen candidate would typically be involved in activities such as (but not exclusively): Definition and scoping of all process improvement activities relating to the area. Leading continuous improvement programs and productivity initiatives. Product impact assessments associated with process deviations. Risk assessments and mitigation projects relating to line performance. Performing process gap analysis and developing strategies to close gaps. Data trend analysis for all performance aspects of the area. Troubleshooting performance trends. Working with the operational excellence group in implementing OE methods, mentoring project leads and facilitating process improvement teams. Review and approval of changes to operating procedures and the change control process relating to the manufacturing lines. Supporting new product introduction teams, as a process subject matter expert. Works in a collaborative manner within the process teams structure and contributes to investigations, cross functional teams within the organization etc. Basic Qualifications: Bachelor s degree in engineering, Science, or related discipline. Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. Significant relevant industrial project experience. Preferred Qualifications: Typically, 3-5 years engineering experience in a manufacturing environment Qualification in Lean and 6-sigma methodologies would be an advantage. New product introduction or process improvement experience in a GMP environment would be advantageous.
Employment Type
Full Time
