About PSC Biotech
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.
Who are we?
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 to work in top pharmaceutical client sites in a diverse‑cultural work setting.
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 to work 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 through 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
We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options, and we will continue to focus on advancing therapies that are the first or best of their kind.
Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain cutting‑edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinate the worldwide movement of our drugs to patients.
Process Engineer – reports to the Senior Manager, Process Engineering and is responsible for ensuring process engineering activities are implemented in a compliant manner. Provides process engineering services to Manufacturing in a Biologics Drug Substance, Drug Product Filling, Packaging, and Labelling facility.
Requirements
The main areas of responsibility are as follows:
Provide technical engineering support and expertise to Packaging & Labelling Operations including equipment performance monitoring, equipment recipe standardisation, troubleshooting and process optimisation.
Represent Engineering on the Packaging & Labelling Operations Process Team and support to deliver uninterrupted supply of commercial product.
Fulfil system ownership responsibilities for all packaging equipment and associated automation recipes required for packaging operations.
Process Engineering system owner representative on key capital projects for area expansion currently being implemented in Packaging across different suites. Provide SME input as part of capital project team on design, qualification, cycle development and GMP release.
Implementation of equipment recipe updates required for artwork updates, SKU launch activities and technology transfers of new products.
Lead and support the investigation and resolution of equipment investigations, ensuring appropriate and effective CAPAs are put in place.
Lead and participate in cross‑functional teams to troubleshoot and resolve technical issues, drive continuous improvement and process optimisation using tools such as DMAIC, SMED and FMEA.
Provide coaching and support to the Packaging Operations and Process Engineering team to build their knowledge.
Partner with serialization SMEs to ensure Packaging is ready to meet changing global requirements.
Participate in cross‑functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day‑to‑day activities.
Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements.
Instil the use of Right First Time (six‑sigma) and lean manufacturing practices leading to operational excellence.
Ensure adherence to high standards of quality and support of a science and risk‑based quality culture.
Providing coaching and support to the Operations team to build their knowledge of packaging processes and associated recipes.
Ensures that all manufacturing methods and practices are consistent with industry and standards.
Maintains professional and technical knowledge by attending workshops, reviewing professional publications; establishing professional networks and participating in professional societies.
Other duties as assigned.
Education and Experience
BA Degree in Engineering – Process, Chemical, Mechanical or equivalent discipline.
Other continuing education initiatives highly desirable – Six Sigma, Lean Manufacturing, industry specific coursework.
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