Validation 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.

Description:

TITLE: Quality Engineer / Validation

Job Purpose:

Reporting to the Business Unit Quality Manager/Staff Validation Engineer, this role is responsible for establishing and ensuring adherence to standardized validation best practices, whilst ensuring that company and external regulatory, quality, and compliance requirements are met.

Responsibilities:

Main areas of responsibility:

Responsible for supporting the activities of Operations / Engineering / Information Management in building product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness.

Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades.

Runs /Manages complaint investigation and resolution of same.

Designs and develops validation documentation to support business continuity, new process/product introductions and process improvement requirements.

Implementation and co-ordination of the change control process promotes timely approval of all supporting documentation.

Implement client policies and procedures.

All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.

Requirements

Education and Experience Required for Role:

Essential:

A Bachelor s degree from accredited college.

3-5 years in a Quality function within the Medical Device/ Pharmaceutical industry.

Desirable:

Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices to Global markets.

Have good knowledge of statistical techniques in the use of problem solving/ data analysis.

Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management.

Ability to demonstrate standards of leadership Managing Complexity/CredoValues/ Innovations/Customer focus.

Flexible

Team Player

Good Influencing Skills

Project Management Skills

Good generalist

Good communication skills

#LI-FP1

Education and Experience Required for Role: Essential: A Bachelor s degree from accredited college. 3-5 years in a Quality function within the Medical Device/ Pharmaceutical industry. Desirable: Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices to Global markets. Have good knowledge of statistical techniques in the use of problem solving/ data analysis. Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management. Ability to demonstrate standards of leadership Managing Complexity/CredoValues/ Innovations/Customer focus. Flexible Team Player Good Influencing Skills Project Management Skills Good generalist Good communication skills #LI-FP1