We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final ...
64 Katalyst Process Engineer Jobs Hiring Near You
We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final ...
Apply manufacturing process knowledge to ensure commissioning scope and acceptance criteria reflect ... Partner with Quality, Manufacturing, and Engineering to support a clean, compliant turnover of ...
Apply manufacturing process knowledge to ensure commissioning scope and acceptance criteria reflect ... Partner with Quality, Manufacturing, and Engineering to support a clean, compliant turnover of ...
Analyzes engineering drawings, and specifications to determine shape, dimensions, hardness etc. in the development of equipment, processes, and products. * Examine feasibility of using one or more ...
Analyzes engineering drawings, and specifications to determine shape, dimensions, hardness etc. in the development of equipment, processes, and products. * Examine feasibility of using one or more ...
This role focuses on aligning stakeholders, evaluating current quality processes and systems, and ... Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field (Master ...
This role focuses on aligning stakeholders, evaluating current quality processes and systems, and ... Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field (Master ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
What makes Katalyst an attractive place to work?
Katalyst is a forward-thinking company that has established itself as a leader in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative and dynamic atmosphere, where employees are encouraged to share ideas and work together to drive progress. Joining Katalyst offers opportunities for professional growth and development, as well as the chance to contribute to meaningful projects that can have a lasting impact.
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Job description
Job Summary:
We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product (FDP) manufacturing environment. The role involves leading commissioning, qualification, and validation activities for both new and existing equipment and processes, ensuring compliance with FDA regulations and internal quality standards. The Sr. Engineer will serve as the site's technical expert for automated systems and combination product validation, collaborating closely with Engineering, Quality, and Manufacturing teams.
Roles & Responsibilities:- Lead commissioning, qualification, and validation activities for automated and semi-automated combination product equipment and processes.
- Author, review, and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Maintain and manage Master Validation Plans and related documentation to ensure compliance with GMP and FDA regulations.
- Serve as the technical SME for automated systems, labeling, and packaging process validation.
- Collaborate with cross-functional teams (Engineering, Quality, Manufacturing) to ensure robust and validated systems supporting 24/7 production operations.
- Conduct on-site and off-shift validation activities as needed to support continuous manufacturing operations.
- Identify process gaps and recommend improvements to optimize validation and operational efficiency.
- Support regulatory audits and inspections by providing accurate and complete validation documentation.
- Bachelor's or Master's degree in Engineering, Life Sciences, or related technical field.
- Proven experience in Commissioning, Qualification, and Validation (CQV) within a GMP-regulated manufacturing environment.
- Hands-on experience with automated and semi-automated equipment, labeling, and packaging operations.
- Strong knowledge of FDA regulations, GMP standards, and internal quality systems.
- Experience with validation documentation including Master Validation Plans, IQ/OQ/PQ protocols, and reports.
- Familiarity with Kneat software is a plus.
- Ability to work flexible schedules, including on-site and off-shift validation activities.