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Senior Validation Engineer
4 months ago
About PSC Biotech
PSC Biotech is a prominent Biotech Consultancy firm established in 1996, headquartered in Pomona, California, USA, with Global operations across various countries including Ireland, India, Singapore, Australia, and the US. We cater to 350 clients in more than 23 countries globally, offering cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.
'Elevate Your Career'
PSC Biotech revolutionizes the traditional consultancy approach by emphasizing our EVP as a key differentiator. Our team consists of exceptionally talented professionals in the Pharma/Biotech Industry. Join us for a permanent role and gain valuable experience working at top Pharmaceutical client sites in a diverse cultural environment.
Employee Value Proposition
Employees are at the core of PSC Biotech. We provide unmatched career development opportunities through in-house training, mentorship, and continuous guidance to support your professional growth. Our focus is on building high-performing teams that exceed client expectations in terms of quality, efficiency, and meeting project deadlines.
Job Description
An opportunity has arisen within the validation team for a Validation Engineer at ***, responsible for executing qualification and validation programs. This role involves planning and implementing sterilization validation activities on critical equipment such as VHP isolators, autoclaves, and CIP/SIP systems. Additionally, the role includes overseeing aseptic processing simulations and HVAC requalification in production environments.
Key Responsibilities:
- Provide technical validation support throughout the validation lifecycle process.
- Develop, review, and approve validation plans, protocols, and reports related to sterilization validation.
- Support aseptic process simulation programs and airflow visualization studies.
- Assist in cycle development, performance qualifications, and requalification activities.
- Collate and analyze validation data and metrics for reporting purposes.
- Contribute to enhancing the validation process while ensuring compliance with regulations and standards.
- Support quality management systems including change control and deviations.
- Coordinate projects and manage workload based on priorities.
- Participate in multidisciplinary teams and regulatory inspections.
- Maintain and update validation Standard Operating Procedures (SOPs).
- Adhere to Good Manufacturing Practices and company policies.
Requirements
Basic Qualifications:
- Bachelor's degree in Science/Engineering or equivalent.
- Familiarity with cGMPs and global regulatory requirements.
- Strong problem-solving skills and effective communication abilities.
- Minimum of 3 years' experience in a similar role.
Preferred Experience:
- Experience in equipment qualification and validation processes as per ASTM E2500.
- Background in qualifying sterilization equipment, isolators, and HVAC systems.
- Knowledge of Quality and Document Management Systems.
- Independent, proactive, and organized with excellent collaboration skills.
- Team player mindset with a focus on collaborative decision-making.
