16 Jobs in La Verne, CA
Katalyst Healthcares & Life Sciences is Hiring a Validation Engineer Near La Verne, CA
- Lead the commissioning and qualification activities for aseptic fill manufacturing equipment, including vial washers, depyrogenation tunnels, isolators, sterile fillers, and cappers.
- Develop and execute qualification protocols (IQ/OQ/PQ) in accordance with regulatory requirements (FDA, EMA, etc.) and company standards.
- Collaborate with cross-functional teams, including engineering, quality assurance, and production, to ensure successful equipment qualification and seamless integration into manufacturing operations.
- Conduct risk assessments and implement appropriate mitigation strategies to ensure the integrity and sterility of the manufacturing process.
- Troubleshoot equipment issues and implement corrective and preventive actions (CAPAs) as needed to maintain equipment performance and compliance.
- Provide technical expertise and support to manufacturing personnel during routine operations, ensuring adherence to standard operating procedures (SOPs) and best practices for aseptic processing.
- Stay current with industry trends, regulations, and advancements in aseptic fill manufacturing technologies, and incorporate best practices into manufacturing processes.
- Bachelor's degree in engineering, pharmaceutical sciences, or related field. Advanced degree preferred.
- Minimum of 7 years of experience in aseptic fill manufacturing, with a focus on commissioning and qualification of equipment.
- Extensive knowledge of regulatory requirements and guidelines governing aseptic processing (e.g., cGMP, Annex 1).
- Proven experience in developing and executing qualification protocols (IQ/OQ/PQ) for aseptic fill manufacturing equipment.
- Strong analytical and problem-solving skills, with the ability to identify and resolve technical issues in a timely manner.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
- Detail-oriented and organized, with a commitment to quality and compliance.
- Experience with risk assessment methodologies and implementation of risk-based approaches to equipment qualification and process validation.
Job Summary
Contractor
$61k-82k (estimate)
06/06/2024
06/22/2024
katalysthls.com
South Plainfield, NJ
<25
Related Companies
The job skills required for Validation Engineer include Problem Solving, Quality Assurance, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Validation Engineer positions, which can be used as a reference in future career path planning. As a Validation Engineer, it can be promoted into senior positions as a Validation Engineer II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Engineer. You can explore the career advancement for a Validation Engineer below and select your interested title to get hiring information.
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