Validation Specialist
Validation Specialist
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3-5years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
At PSC Biotech we are dedicated to ensuring that life sciences products are developed manufactured and distributed to the highest standards meeting all regulatory requirements and exceeding industry expectations. Our mission is to accelerate the success of our clients by providing essential services that support the creation of lifesaving products.
With a global presence spanning North America and Europe Asia and the Middle East we take immense pride in the work we do and the talented professionals who contribute to our success. Join us in helping to shape the future of healthcare.
At PSC Biotech we bring together the brightest minds from across the globe to create a dynamic and inclusive work environment. Our multicultural teams are passionate about achieving excellence and innovation and we believe in the power of collaboration to drive success. When you join our team you ll not only be part of a company with a rich legacy of helping clients succeed but you ll also be allowed to inspire and be inspired in your career.
We are committed to developing the next generation of leaders in the life sciences industry. Beyond competitive compensation and benefits we provide you with the resources training and mentorship to help you thrive and advance in your career.
At PSC Biotech we offer more than just a job it s an opportunity to build your future.
Your Role:
We are seeking a Validation Specialist with handson experience in validation and asset management within the pharmaceutical or biotech industry. This role will focus on ensuring that all equipment systems and processes meet regulatory requirements and quality standards while managing effective regulatory asset management. The ideal candidate will have strong experience with asset management systems including Blue Mountain RAM and a deep understanding of calibration processes and preventative maintenance protocols.
Key Responsibilities:
- Lead and support validation activities ensuring compliance with all applicable regulatory requirements (cGMP FDA EMA etc. and industry standards.
- Develop review and execute validation protocols for equipment utilities systems and processes ensuring robust compliance and reliability.
- Write review and approve technical documentation including SOPs validation plans protocols risk assessments and validation summary reports.
- Assist in the creation and revision of SOPs to ensure alignment with regulatory and quality requirements for validation activities.
- Collaborate with crossfunctional teams to ensure validation activities align with project goals timelines and regulatory expectations.
- Manage Blue Mountain RAM (Regulatory Asset Management) systems for asset lifecycle tracking and regulatory compliance ensuring effective management of all validated assets.
- Oversee calibration activities ensuring that all equipment is properly calibrated according to regulatory requirements.
- Address situations where calibration may have been overlooked identifying potential risks and ensuring timely corrective actions are implemented.
- Implement and monitor preventative maintenance programs including gasket maintenance and replacement to ensure the longevity and reliability of critical systems and equipment.
- Perform risk assessments and recommend process improvements to enhance compliance and operational efficiency.
- Support investigations deviations and change control processes evaluating the impact of changes to systems processes and equipment and ensuring proper validation procedures are followed.
- Ensure regulatory documentation related to asset management and validation activities is accurately maintained and up to date.
- Support the validation team in maintaining an accurate record of all validation activities and related documentation.
- Additional responsibilities as required by the project or client needs.
Requirements
- Bachelor s degree in Engineering Life Sciences or a related field.
- A minimum of 3 years of experience in validation activities within the pharmaceutical/biotech industry.
- Experience with Blue Mountain RAM (Regulatory Asset Management) or similar systems is highly preferred.
- Proven experience with asset management systems in life sciences particularly in managing validated assets throughout their lifecycle.
- Strong knowledge of calibration processes and experience in addressing calibration discrepancies or overlooked calibrations.
- Experience with preventative maintenance programs including the management of gaskets and other critical components.
- Indepth knowledge of regulatory requirements and industry standards (cGMP GDP FDA EMA).
- Strong experience in SOP creation revision and implementation.
- Excellent analytical and problemsolving skills with meticulous attention to detail.
- Strong communication skills with the ability to collaborate effectively across multidisciplinary teams.
- Ability to work independently while managing multiple priorities in a fastpaced environment.
- Flexibility and willingness to travel as required for project assignments and client engagements.
- Ability to adapt to different locations cultures and work environments to collaborate effectively with clients and colleagues.
Preferred Requirements:
- Aseptic Processing experience a plus.
- Aseptic Operations experience a plus.
- This is a projectbased role through March 2026 with potential for extension or renewal.
- This position requires working from 8:00 PM to 5:00 AM Philippine time. Candidates must be comfortable with this schedule as it aligns with project and client needs.
Benefits
Blue Mountain RAM, Regulatory Asset Management, Calibration, Asset Management, Life Science, Pharmaceutical, Validation
Employment Type
Full Time
