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 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 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 through Learning & Development in‑house training, mentorship and 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.
A fantastic opportunity has arisen for a Validation Specialist. The successful candidate will take a lead on utilising the latest innovations in technology. The role is based at the Drug Substance and Drug Product Facility in Co. Louth, a new facility build working to obtain qualification and continued product development. The site is the first facility in the network focused on manufacturing a live virus vaccine.
Bring energy, knowledge, innovation to carry out the following:
Support the site validation activities across a number of workstreams.
Support site EMPQ strategy and implement/maintain EM protocols and procedures for graded pharmaceutical areas, ensuring compliance with regulatory guidelines.
Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and subsequent requalification/revalidation.
Support global regulatory submissions, internal audits and external inspections/audits as needed.
Facilitate problem solving & risk assessment projects/meetings.
Making problems visible and strive for continuous improvement.
Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
Keep up to date with scientific and technical developments.
Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
Requirements
What skills you will need:
In order to excel in this role, you will more than likely have:
3‑5 years direct experience with a pharmaceutical or biotechnology company with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.
Experience in Facility, Utility and Equipment qualifications, examples include CTUs, Parts Washers, Autoclaves, Clean Utilities, Cleanrooms/HVACs etc.
Prior experience with upstream cell culture and/or downstream formulation/fill finish processes.
Prior experience with technology transfer, regulatory filing, and commercial drug substance/drug product manufacturing.
Prior experience in drug substance/drug product, process performance qualification and validation, site readiness and authoring regulatory CTD sections.
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