This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial ...

60 Katalyst Consulting Jobs Hiring Near You
This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial ...
Contract Manager
$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
$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 ...
Consultants will be responsible for hands-on execution of equipment commissioning and qualification activities, including reviewing and executing established qualification protocols, documenting test ...
Consultants will be responsible for hands-on execution of equipment commissioning and qualification activities, including reviewing and executing established qualification protocols, documenting test ...
Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems. * Strong ...
Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems. * Strong ...
Process Engineer
Frederick, MD · On-site
This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial ...
Process Engineer
Frederick, MD · On-site
This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial ...
Process Engineer
Durham, 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
Durham, NC · On-site
This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial ...
CSV Engineer
Boston, MA · On-site
Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results ...
CSV Engineer
Boston, MA · On-site
Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results ...
Packaging Process Engineer
Durham, NC · On-site
This consultant will provide technical leadership for pharmaceutical packaging operations, supporting equipment implementation, commissioning, qualification, process optimization, and commercial ...
Packaging Process Engineer
Durham, NC · On-site
This consultant will provide technical leadership for pharmaceutical packaging operations, supporting equipment implementation, commissioning, qualification, process optimization, and commercial ...
Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible ...
Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible ...
CSV Engineer
Raritan, NJ · Remote
$73K - $95K/yr
Effective leadership and mentoring skills, guiding cross-functional and external teams (Senior and Junior consultants). * Strong project coordination and stakeholder communication skills, including ...
CSV Engineer
Raritan, NJ · Remote
$73K - $95K/yr
Effective leadership and mentoring skills, guiding cross-functional and external teams (Senior and Junior consultants). * Strong project coordination and stakeholder communication skills, including ...
Bachelor's degree in Business, Engineering, Procurement, Legal, Quantity Surveying, Cost Consulting, or related field required. * Master's degree (MBA/MS) preferred.
Bachelor's degree in Business, Engineering, Procurement, Legal, Quantity Surveying, Cost Consulting, or related field required. * Master's degree (MBA/MS) preferred.
Senior Business Analyst
Warren, NJ · On-site
$95K - $123K/yr
Partner with Veeva technical consultants and configuration teams to ensure accurate delivery of requirements. * Support the design of document lifecycle workflows and training record structures ...
Senior Business Analyst
Warren, NJ · On-site
$95K - $123K/yr
Partner with Veeva technical consultants and configuration teams to ensure accurate delivery of requirements. * Support the design of document lifecycle workflows and training record structures ...
Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management ...
Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management ...
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
Packaging Process Engineer
Raleigh, NC · On-site
This consultant will provide technical leadership for pharmaceutical packaging operations, supporting equipment implementation, commissioning, qualification, process optimization, and commercial ...
Packaging Process Engineer
Raleigh, NC · On-site
This consultant will provide technical leadership for pharmaceutical packaging operations, supporting equipment implementation, commissioning, qualification, process optimization, and commercial ...
Regulatory Affairs Manager
Charlotte, NC · On-site
... consultants as needed. * Document regulatory strategies for product submissions. * Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays
Regulatory Affairs Manager
Charlotte, NC · On-site
... consultants as needed. * Document regulatory strategies for product submissions. * Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays
Validation Engineer
Springfield, MA · On-site
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
Validation Engineer
Springfield, MA · On-site
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
Equipment Maintenance Technician 2
Sparks, MD · On-site
Uses judgment and consultation to analyze, troubleshoot and repair complex equipment and machinery. Must project positive attitude with good team skills. Effectively works in a team setting ...
Equipment Maintenance Technician 2
Sparks, MD · On-site
Uses judgment and consultation to analyze, troubleshoot and repair complex equipment and machinery. Must project positive attitude with good team skills. Effectively works in a team setting ...
Equipment Maintenance Technician 2
Sparks, MD · On-site
Uses judgment and consultation to analyze, troubleshoot and repair complex equipment and machinery. Must project positive attitude with good team skills. Effectively works in a team setting ...
Equipment Maintenance Technician 2
Sparks, MD · On-site
Uses judgment and consultation to analyze, troubleshoot and repair complex equipment and machinery. Must project positive attitude with good team skills. Effectively works in a team setting ...
Katalyst Jobs Information
What is it like to work at Katalyst?
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.
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Job description
- Seeking an experienced Process Engineer - Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial manufacturing.
- Working closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual will ensure cartridge filling processes consistently meet production, quality, and regulatory objectives while supporting the successful startup of new manufacturing operations.
- Direct experience supporting cartridge filling lines is required. Candidates with experience limited to syringe filling will not be considered.
Requirements:
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
- 5+ years of pharmaceutical manufacturing experience, preferably supporting sterile injectable operations.
- Hands-on cartridge filling experience is required.
- Strong understanding of FDA cGMP regulations, EU GMP, Annex 1, and aseptic manufacturing principles.
- Experience supporting equipment validation, process qualification, and manufacturing startup activities.
- Excellent troubleshooting, communication, and technical writing skills.
Most Important Skills Needed:
- Direct cartridge filling line experience (Required)
- Process Engineering within sterile pharmaceutical manufacturing
- Aseptic filling operations
- Equipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ)
- Process optimization and manufacturing troubleshooting
- GMP manufacturing experience
- Root cause investigations, CAPA, and deviation support
- Cross-functional collaboration with Manufacturing, Validation, Automation, and Quality
- Technical documentation, engineering studies, and protocol development