Katalyst CRO
Posted 19 days agoVerified live 2d ago
Packaging Development Engineer
Brief overview
Remote
UndergradOr in progress
2+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Packaging DevelopmentPackage EngineeringPackaging MaterialsPackaging ValidationPerformance TestingCAD SoftwarePackaging SpecificationsPackaging DrawingsGMP ComplianceFDA RegulationsISO StandardsASTM StandardsISTA StandardsPackaging Equipment ValidationSupplier QualificationDesign History FilesChange Control
About the company
Katalyst CROkatalysthls.com
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
Visa sponsorship history
4 years sponsoring, last filed FY2026
Data powered by U.S. Department of Labor. This does not guarantee sponsorship for this specific role.32H-1B approved
89%approval rate
3new H-1B hires
9PERM certified
$240,000median wage / yr
H-1B Petition ApprovalsVisas USCIS actually granted: the strongest sign the company sponsors.
202319
20249
20254
LCA Certified ApplicationsAn early filing step, not a visa approval: it signals intent, not confirmed sponsorship.
20236
20242
20259
20262
Green Card (PERM) FilingsCertified green card filings: a long-term commitment to international hires.
20235
20241
20253
Top sponsored roles
VALIDATION ENGINEERQUALITY ENGINEERCLINICAL DATA ANALYSTPRODUCT DEVELOPMENT ENGINEERCLINICAL DATA MANAGER
Sponsored employees from
India
Job description
Summary
Katalyst CRO is seeking a Packaging Development Engineer to design, develop, validate, and optimize packaging systems for new and existing products. This role involves collaboration with R&D, Manufacturing, Quality, Regulatory, and Supply Chain teams to ensure packaging solutions meet various requirements.
Responsibilities
- Design and develop primary, secondary, and tertiary packaging solutions for new and existing products
- Lead packaging development projects from concept through commercialization
- Evaluate packaging materials and components for functionality, quality, and cost-effectiveness
- Develop packaging specifications, drawings, and technical documentation
- Plan and execute package validation activities, including transit, distribution, and shelf-life testing
- Collaborate with suppliers to qualify new packaging materials and resolve technical issues
- Support manufacturing line trials, packaging equipment validation, and process improvements
- Conduct root cause investigations and implement corrective actions for packaging-related issues
- Ensure compliance with GMP, FDA, ISO, ASTM, ISTA, and other applicable standards
- Partner with cross-functional teams including Engineering, Quality, Regulatory Affairs, Operations, and Procurement
- Support cost reduction, sustainability, and continuous improvement initiatives
- Maintain Design History Files (DHF), change controls, risk assessments, and technical reports
Skills
- Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, Materials Science, or a related engineering discipline
- 2–5 years of experience in packaging development, package engineering, or product development
- Experience with packaging materials such as plastics, paperboard, corrugated packaging, labels, films, foams, or glass
- Knowledge of packaging validation and performance testing
- Experience working with CAD software for packaging design is preferred
- Strong problem-solving, analytical, and project management skills
- Excellent written and verbal communication skills
- Experience in pharmaceutical, medical device, biotechnology, consumer products, food & beverage, or manufacturing industries
- Knowledge of ISTA, ASTM, ISO 11607, FDA, and GMP requirements
- Experience with packaging line equipment and automation
- Familiarity with Lean Manufacturing, Six Sigma, or Design for Manufacturability (DFM)
- Experience with supplier qualification and package commercialization
Qualifications
Must Haves
- Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, Materials Science, or a related engineering discipline
- 2–5 years of experience in packaging development, package engineering, or product development
- Experience with packaging materials such as plastics, paperboard, corrugated packaging, labels, films, foams, or glass
- Knowledge of packaging validation and performance testing
- Experience working with CAD software for packaging design is preferred
- Strong problem-solving, analytical, and project management skills
- Excellent written and verbal communication skills
Nice to Haves
- Experience in pharmaceutical, medical device, biotechnology, consumer products, food & beverage, or manufacturing industries
- Knowledge of ISTA, ASTM, ISO 11607, FDA, and GMP requirements
- Experience with packaging line equipment and automation
- Familiarity with Lean Manufacturing, Six Sigma, or Design for Manufacturability (DFM)
- Experience with supplier qualification and package commercialization
