Senior Process Engineer-Hybrid
Senior Process Engineer-Hybrid
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Job Description
About PSC Biotech
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 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 point 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.
Overview:
A new position has arisen in our growing Manufacturing Science & Technology (MS&T) team for a 6 month contract for a Senior Process Engineer to support Upstream Manufacturing a stateoftheart facility which delivers lifesaving medication to patients all over the world at speed and scale. The site offers over 400 colleagues the chance to work in a pivotal hub of biologicsbased medicines.
Requirements
Role Functions:
- Lead assist in and facilitate investigations ensuring effect Root Cause Analysis and CAPAs data analysis and interpretation to resolve complex cell culture deviations.
- Lead process improvement and troubleshooting with endtoend product focus.
- Support the industry 4.0 initiative to navigate operations and data analytics in a digital environment.
- Provide technical support to new process introduction or change implementation in commercial manufacturing operations.
- Author and review batch documentation technical reports and supporting global regulatory submissions as needed.
- Provide technical guidance to members of the process engineering team and IPT
- Support execution data analysis and interpretation of trends observed in commercial process monitoring (e.g. proactive process analysis continued process verification statistical process control multivariate analyses)
- Lead and/or support various site initiatives to improve compliance status and overall operational efficiency of the site
- Lead and/or support the execution of development and PPQ batches
- Resolve issues and identify risks in a timely fashion. Ensure project milestones are achieved through planning and execution of integrated overall program schedule
Experience Knowledge & Skills:
- Proven ability in collaboration and crossfunctional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site
- Proven ability to effectively initiate and drive change across the site
- Strong verbal and written communication skills project management skills
- Strong Experience with Upstream processing and troubleshooting including Tech Transfer regulatory filing and commercial manufacture
- Experience in leading complex investigations
- Experience in supporting regulatory inspections
- Working knowledge of current regulatory requirements and current Good Manufacturing Practices
Qualifications & Education:
- This role requires an experienced individual with a degree (or higher) in Science Engineering Technical or equivalent
- Minimum 6 years operational support (or 4 years plus Tech Support) in Biopharma industry with direct experience of USP biologics manufacture facility commissioning qualification validation and startup
This role requires an experienced individual with a degree (or higher) in Science, Engineering, Technical or equivalent Minimum 6 years operational support (or 4 years plus Tech Support) in Biopharma industry, with direct experience of USP biologics manufacture, facility commissioning, qualification, validation and startup
Education
This role requires an experienced individual with a degree (or higher) in Science, Engineering, Technical or equivalent Minimum 6 years operational support (or 4 years plus Tech Support) in Biopharma industry, with direct experience of USP biologics manufacture, facility commissioning, qualification, validation and startup
Employment Type
Full Time
