Validation Engineer
Enola, PA · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
60 Katalyst Consulting Jobs Hiring Near You
Validation Engineer
Enola, PA · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
Lafayette, IN · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
Lafayette, IN · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
San Francisco, CA · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
San Francisco, CA · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
Elmore, OH · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
Elmore, OH · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
Raleigh, NC · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
Raleigh, NC · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
Kenosha, WI · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
Kenosha, WI · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
San Francisco, CA · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
San Francisco, CA · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
Rock Hill, SC · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
Validation Engineer
Rock Hill, SC · On-site
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
As a Statistical Programming Consultant, you will use your SAS and R programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create related documents such ...
As a Statistical Programming Consultant, you will use your SAS and R programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create related documents such ...
CSV Lead
Lancaster, PA · On-site
$99K - $131K/yr
The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on ...
CSV Lead
Lancaster, PA · On-site
$99K - $131K/yr
The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on ...
CSV Lead
$101K - $133K/yr
The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on ...
CSV Lead
$101K - $133K/yr
The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on ...
CSV Lead
Philadelphia, PA · On-site
$98K - $129K/yr
The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on ...
CSV Lead
Philadelphia, PA · On-site
$98K - $129K/yr
The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on ...
Architect/Lead
Knoxville, TN · Hybrid
$52.75 - $72.25/hr
Collaborate with functional consultants, business users, and project teams during implementation and support phases. * Provide production support and continuous improvement recommendations.
Architect/Lead
Knoxville, TN · Hybrid
$52.75 - $72.25/hr
Collaborate with functional consultants, business users, and project teams during implementation and support phases. * Provide production support and continuous improvement recommendations.
Contract Manager
Portsmouth, NH · On-site
$90K - $121K/yr
... Consultants). * The position is expected to act as a commercial expert working in close cooperation and coordination together with the Global Engineering team (SGIE), the local project team and any ...
Contract Manager
Portsmouth, NH · On-site
$90K - $121K/yr
... Consultants). * The position is expected to act as a commercial expert working in close cooperation and coordination together with the Global Engineering team (SGIE), the local project team and any ...
Collaborate with international personnel and external consultants to deliver against the project plan. * Support international registrations and renewals as needed.
Collaborate with international personnel and external consultants to deliver against the project plan. * Support international registrations and renewals as needed.
CSV Lead (Managed Services)
South Plainfield, NJ · On-site
$107K - $141K/yr
Manage and support CSV Consultants on execution responsibilities & be direct interface to customer FT team. * Support Engagement Lead with resource interviews, allocation, utilization, schedule ...
CSV Lead (Managed Services)
South Plainfield, NJ · On-site
$107K - $141K/yr
Manage and support CSV Consultants on execution responsibilities & be direct interface to customer FT team. * Support Engagement Lead with resource interviews, allocation, utilization, schedule ...
CSV Lead
Watertown, MA · On-site
We are seeking a Lead CSV / Validation Consultant (Director-Level) for a biotech client with an upcoming FDA inspection. This is a critical position focused on program maturity, SaaS validation, and ...
CSV Lead
Watertown, MA · On-site
We are seeking a Lead CSV / Validation Consultant (Director-Level) for a biotech client with an upcoming FDA inspection. This is a critical position focused on program maturity, SaaS validation, and ...
CSV Engineer
Redwood City, CA · On-site
Our client is looking for an experienced and well-rounded CSV (Computer System Validation) Consultant to support multiple ongoing projects within a pharmaceutical environment. The ideal candidate ...
CSV Engineer
Redwood City, CA · On-site
Our client is looking for an experienced and well-rounded CSV (Computer System Validation) Consultant to support multiple ongoing projects within a pharmaceutical environment. The ideal candidate ...
Process Engineer
Raleigh, NC · On-site
This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial ...
Process Engineer
Raleigh, NC · On-site
This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial ...
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.
What are the most popular job types at Katalyst?
What are the most popular jobs at Katalyst?
What are the most popular categories at Katalyst?
Job description
Responsibilities:
- Client is seeking validation consultants to support a 9-month minimum onsite project in South Carolina. The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification.
- The project is being driven by audit findings and identified gaps in the site's validation program. The primary focus will be equipment validation, especially around tanks used for drug substance mixing and drug product filling. The team needs to assess whether existing IOQ/OQ documentation is robust enough, identify gaps between OQ and PQ, and determine whether current qualifications can support performance qualification expectations.
- The consultants will also support product-specific mixing study needs, including evaluating mixing from an equipment qualification perspective. This includes understanding tank qualification, viscosity considerations, matrix/bracketing approaches, risk assessment, and how to identify, group, and mitigate validation gaps.
- The team will also support smoke study execution in an aseptic processing environment. The site has a tunnel and two lyophilizers, so candidates should understand aseptic technique, equipment operation, and how to drive execution as a validation representative.
- This role is execution-heavy, but the client also needs consultants who can perform gap assessments and provide guidance on validation strategies. The lead consultant should be able to drive the project, guide internal resources, manage execution, and keep the validation effort moving forward.
Requirements:
- Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred. Equivalent hands-on validation experience can be considered.
- Include Must Have:
- Validation execution experience in a pharmaceutical, biotech, or aseptic manufacturing environment.
- Equipment qualification experience.
- Strong understanding of IOQ/OQ/PQ expectations.
- Ability to perform gap assessments.
- Tank qualification experience.
- Mixing study experience or strong understanding of equipment-based mixing qualification.
- Aseptic processing experience.
- Smoke study experience or strong understanding of smoke study execution.
- Ability to support protocol execution and documentation.
- Ability to assess whether qualification packages are robust enough.
- Ability to identify validation gaps and recommend mitigation strategies.
- Ability to handle a strong personality and drive work forward without being timid.