csv EngineerPSC Biotech

Job Description:
PSC Biotech provides life sciences with essential services to ensure that healthcare products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professional and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
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The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it's about more than just a job-it's about your career and your future.
Your Role
We are hiring a CSV Engineer with at least 4+ years of experience in computer systems validation. The candidate must have strong experience with test script writing. Supervisory experience is preferred.
Responsibilities
Perform execution of CSV protocols
Generate and execute validation documents (System Testing, IQ, OQ, PQ, UAT)
Provide range of support in a variety of CSV tasks
Participate/support the planning, development, and implementation of computer systems validation documentation
Initiate and oversee system CSV associated change control requests and associated validation documentation
Author, Review and or approve scheduled periodic reviews
Participate in computer validation project activities and create computer system planning documents and testing protocols
Review test results and identify areas of improvement to implement changes.
Review and modify Standard Operating Procedures (SOPs)
Review and analyze validation data -compiling reports when required
Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements
Requirements
4+years of CSV experience is required
Knowledge of validation of cGxP computerized systems within FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, and applicable predicate regulations
Strong attention to detail
Excellent communication and interpersonal skills
Ability to prioritize tasks in an organized, effective manner
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PSC Biotech

Makati City, Metro Manila
Permanent
Full-time