Senior CQV Engineer

About PSC Biotech Ltd

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.

Essential Functions

• Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
• Quality SME for the execution and reporting phases of the qualification and validation activities.
• Ensure any investigations / deviations associated with the validation activities are thoroughly investigated and closed in a timely manner
• Write, review, approve and execute commissioning and qualification documents (equipment and facility)
• Working with the Project Manager plan validation project schedules and prioritize validation activities in line withprojectschedules
• Attend and sign-off on construction walk downs
• Managing the preparation of equipment test runs
• Complete review of vendor & construction docs to support commissioning and qualification activities
• Ensure non-conformances and deviations are minimised and closed out in a timely manner
• Attend project meetings with senior management and report progress
• Supervision of contractors/vendors during commissioning
• Preparation of commissioning and qualification summary reports
• Manage commissioning and qualification of equipment and facility
• Identify and implement system optimisations where required
• Provide validation related support to all departments

Requirements

Experience required:

• 5+ years’experience in a QA/Validation related position within the pharmaceutical orlife sciencesindustry.

• Strong experience with Validation in project related activitiesi.e.,Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.
• Strong experience in Validation to ensure compliance toappropriate regulations and guidelines
• Strong experience of Computer System Validation regulations
• Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
• Track record of utilizing Risk Based Approaches to Qualification / Validation activities.

• Strong track record of identifying,escalating,and correcting compliance issues and implementing process improvements.

• Excellent attention to detail and good documentation practices

• Ability to understand project plans and schedules

• Strong written and oral communication skills

• Strong knowledge of GxP

• Process validation experience (including protocol write up and execution).

Education and Skills Requirements

• Degree in a Science, Engineering or Other related technical discipline
• Project management experience a plus
• Ability to analyse data and make recommendations
• Experience in working with cross functional teams
• Excellent report, standards, technical writing skills
• Proficiency in Microsoft Office suite and job-related computer applications required