Validation Technical Specialist

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:

An amazing opportunity has arisen for a Technical Specialist Vaccines IPT. The Technical Specialist will provide validation and technical support to the Vaccines IPT team and the role will be reporting to the Vaccines IPT Associate Director.

Responsibilities:

Execute and provide technical support for transform the business activities within the Vaccine IPT.

Execute and provide technical support for Building 8 upgrade project.

Execute the validation of equipment, cleaning, utility systems, facilities, processes and/or automation systems for projects. This includes adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports

Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT

Technical report writing, statistical analysis of data

Support the completion of validation projects through adhering to validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing

Adherence to the latest regulatory guidelines.

Apply Lean Six Sigma and Lean methodologies to drive a culture of Continuous Improvement within the IPT.

Represent the IPT on cross-functional project teams.

Provide technical input and support and present as an SME on relevant topics during regulatory inspections.

Assess and align Technical IPT priorities to the IPT and in turn site strategic map.

Adherence to highest standards for Compliance (Quality and Safety)

Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.

Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Requirements

Qualifications:

3-5 years experience as a validation/qualification specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field.

Experience in at least three of the following areas: Cleaning Validation, Process and Equipment validation, Process operations or manufacturing, Process Engineering, Technology transfer,

A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.