Katalyst
Katalyst

72 Katalyst Lead Engineer Jobs Hiring Near You

Lead and execute commissioning and qualification activities for new secondary and tertiary ... Collaborate with equipment vendors, engineering, construction, and operations teams to ensure ...

A Software Engineer who works within a development team to lead the development of infotainment software with a focus on headunit software, creating a top-class infotainment platform that applied to ...

Lead/Support a Veeva LIMS implementation and the validation activities throughout the system ... Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical ...

Requires a BS or MS in engineering. * All the skills and abilities of Engineer L1. * Additionally, must be proficient in technical writing and possess computer skills for scientific and technical ...

The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). * This role ...

We are seeking an experienced Senior Validation Engineer / Senior CQV Engineer to support commissioning, qualification, and validation activities for equipment, systems, software, and manufacturing ...

Lead initiatives to enhance Quality Management Systems (QMS) across manufacturing operations ... Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field (Master ...

Perform engineering calculations with respect to strength of materials, speeds, horsepower, temperature, pressure, force, etc. as related to machine and tool designs. * Analyzes engineering drawings ...

Summary: The Procurement Specialist is responsible for supporting sourcing activities, managing supplier relationships, and ensuring timely procurement of materials and services. This role works ...

Required Qualifications : * Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every ...

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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.

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.

What other companies are hiring for Lead Engineer jobs?

Infographic showing various Lead Engineer job openings at Katalyst in the United States as of September 2026, with employment types broken down into 97% Full Time, 2% Part Time, and 1% Nights. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution.

Full-time

Re-posted 25 days ago


Job description

Job Summary:
  • We are looking for an experienced Commissioning & Qualification (C&Q) Engineer to join our team in support of a major capital expansion project involving the installation of four new packaging lines.
  • This is a hands-on C&Q role embedded within a pharmaceutical secondary and tertiary packaging operation for final drug product.
  • This is not a validation role - we are looking for a true C&Q professional with deep expertise in equipment commissioning, system turnover, and manufacturing process knowledge within a regulated pharmaceutical environment.
  • You will be responsible for leading and executing commissioning and qualification activities across new packaging equipment installations, ensuring all systems are built, installed, and functionally verified to specification and ready for handover to GMP manufacturing operations.
Roles & Responsibilities:
  • Lead and execute commissioning and qualification activities for new secondary and tertiary packaging equipment installations across four new packaging lines in Building 2
  • Develop, author, review, and execute C&Q documentation including commissioning plans, commissioning protocols, test scripts, punch lists, and turnover packages
  • Perform hands-on equipment walkdowns, system verifications, and commissioning checks directly on the manufacturing floor
  • Manage punch list identification, tracking, and resolution through to system acceptance and turnover
  • Collaborate with equipment vendors, engineering, construction, and operations teams to ensure systems are installed, functional, and commissioned to design specification
  • Support and execute SAT (Site Acceptance Testing) activities for incoming packaging equipment
  • Ensure all C&Q activities are performed in compliance with FDA, GMP, and applicable site and regulatory standards
  • Apply manufacturing process knowledge to ensure commissioning scope and acceptance criteria reflect real-world operational requirements
  • Partner with Quality, Manufacturing, and Engineering to support a clean, compliant turnover of commissioned systems into GMP operations
  • Maintain accurate and complete C&Q records in compliance with site documentation standards and data integrity requirements
Experience:
  • Experienced Commissioning & Qualification (C&Q) professional with deep expertise in equipment commissioning, system turnover, and manufacturing process knowledge within a regulated pharmaceutical environment
  • Experience supporting pharmaceutical secondary and tertiary packaging operations for final drug product
  • Hands-on experience in equipment commissioning, system turnover, and manufacturing floor execution
  • Knowledge of FDA, GMP, and applicable site and regulatory standards