Process Engineer

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.

Overview:

A fantastic opportunity has arisen for an API Process Engineer. The successful candidate will provide technical support for production across various API facilities on site. These are exciting and challenging opportunities to work on multiple projects, ranging from manufacturing support activities to late-stage clinical product development and scale-up, new product introductions and technology transfers.

Responsibilities:

A key contributor and guiding the site on a new product introduction or technical transfer to and from the site, including new technologies.

You will work as part of a multi-functional, diverse team to deliver results within schedule and product launch milestones, this may involve directing day to day will development plans across projects and working closely with Research and Development partners globally.

Specifically, the role involves evaluation of raw materials, development of process fits, optimisation and development of the chemical API process, participation in campaign preparation, safety and environmental reviews, batch sheet reviews, regulatory and validation compliance, process monitoring, deviation investigations and resolution, and developing filing strategies.

The successful candidate will have an aptitude for technical problem solving, with a background in solving technical issues to obtain a positive outcome.

Knowledge and subject matter expertise on API processing unit operations and scale up opportunities are a core part of the role, with the ability to identify and overcome constraints and tests to ensure successful demonstration of processes through piloting and validation.

Requirements

Experience, Knowledge and Skills:

Experience in process modelling/simulation and/or data analytics would be an advantage

Demonstrated ability to be self-motivated and focus others with respect to implementing identified improvement initiatives.

Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.

High personal integrity, credibility and energy.

Demonstrated ability to work as part of diverse teams.

Qualifications:

B.S. or M.S. degree in Chemical Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with minimum of 1 year experience in API production or related environment

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