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Jobs or company...

Chemical / Process Engineer

Salary undisclosed

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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.

Key Responsibilities:

  • Act as the Process Engineering representative for biologics DS manufacturing, ensuring effective communication and collaboration among Process Unit, MS&T, C&Q, and QA teams.
  • Serve as the Subject Matter Expert (SME) in collaboration with external service providers, overseeing design and equipment modifications for expansion projects in the manufacturing facility.
  • Provide technical expertise on CIP, SIP systems, and Sterilization Autoclaves, focusing on operational philosophy, alarm and monitoring concepts, equipment design considerations, and troubleshooting.
  • Lead CIP circuit design and recipe qualification activities for New Product Introductions (NPI) or Capital Expenditures (CAPEX), ensuring alignment with cleaning validation deliverables in collaboration with MSAT validation.
  • Support commissioning and qualification (C&Q) activities related to equipment and CIP/SIP circuit automation as part of new product introduction, ensuring compliance with industry standards and regulations.
  • Manage deviation documentation and reporting requirements during commissioning activities, ensuring all activities meet client standards and organizational quality expectations.

Qualifications:

  • Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
  • Minimum of 5 years of experience in process engineering within the biologics or pharmaceutical industry, with a strong focus on manufacturing operations.
  • Proven expertise in CIP/SIP systems and sterilization processes.
  • Strong understanding of commissioning and qualification processes for manufacturing equipment and automation systems.
  • Excellent problem-solving skills, attention to detail, and ability to manage multiple projects simultaneously.
  • Strong communication skills and the ability to work collaboratively with Cross-functional teams, external service providers, and stakeholders.
  • Familiarity with regulatory requirements and industry standards (e.g., GMP, FDA regulations) relevant to biologics manufacturing.
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