What are the responsibilities and job description for the Senior Validation Engineer position at Katalyst HealthCares & Life Sciences?
Responsibilities
- Lead the development and execution of commissioning, qualification, and validation protocols for a range of laboratory equipment, facility systems, and utilities.
- Draft, review, author, and deploy all required validation documentation including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, and so on.
- Provide technical expertise throughout the validation lifecycle including risk assessment, deviation investigation, and change control activities.
- Effectively identify potential risks and areas of improvement and proactively implement risk mitigation.
- Document test results, deviations, and investigations in compliance with company procedures and regulatory standards.
- Perform temperature mapping studies for controlled environments, lab spaces, warehouses, CTUs, etc. leading all test activities, report generation, and improvement initiatives.
- Collaborate with cross functional teams to support all project timelines and deliverables and be able to drive successful validation of critical systems and equipment.
- Contribute to the continuous improvement of validation processes and procedures.
- Always ensure compliance with industry regulations and requirements.
- Bachelor's degree in related engineering discipline.
- 7-10 years of commissioning, qualification, and validation execution experience in the pharmaceutical/life science industry.
- Extensive knowledge and experience executing validation protocols and procedures for a range of laboratory equipment, facilities, and utilities.
- Experienced with paperless validation systems (Val Genesis, KNEAT, etc.).
- Project Management experience is a plus.
- Experience leading validation projects from start to finish.
- Experienced in temperature mapping procedures and activities.
- Strong knowledge of controlled systems.
- Strong background in risk-based validation approaches.
- Strong understanding of regulatory requirements including cGMP, FDA, etc.
- Strong analytical skills with the ability to solve problems and troubleshoot effectively.
- Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
- Detail-oriented mindset with a commitment to maintaining high-quality standards.
- At PSC Biotech, many of our projects and clients are in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements.
- The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
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