Katalyst CRO ยท 1 month ago
Process Engineer
Jersey City, NJ
Contract
Onsite
Mid, Senior LevelKatalyst Healthcares & Life Sciences is seeking a Process Engineer to lead process design efforts from modeling through to pilot scale and qualification. The role involves driving process and product characterization, collaborating with supply chain, and mentoring earlier career engineers in process design.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead process design efforts from modeling through to pilot scale and qualification, including technical reviews
Drive process and product characterization to ensure rigorous technical understanding meets scale-up metrics and KPIs (such as scrap, cost and quality)
Lead raw material suppliers through raw material iterations, correlating to product design window
Drive execution of Learning Plans, seamlessly collaborating with Supply Chain
Peer review, coach and develop earlier in career engineers with respect to Process Design
Successful experience in scaling up multiple new formulations (from modeling through to production scale) is required. Experience in biomaterials and material development highly preferred
Experience in Medical Device industry is preferred; experience in combination products is preferred. Experience with respect to PMA preferred
Proven problem-solving skills using analytical technologies is preferred
Experience in the following processes (at multiple scales) is required: Powder handling, filling, mixing, transport, isolation, polymer synthesis and reaction (more may be added)
Experience Design of Experiments (DOE) is required
Experience in developing protocols and writing completion reports is preferred
Experience in vitro and ex vivo methods for characterizing prototypes and products is preferred
Excellent communication, collaboration and influencing skills
Demonstrated ability to deliver project outcomes in an ambiguous environment
Requires experience managing self-directed work teams
Travel up to 20% may be required (domestic and international)
Qualification
Required
Successful experience in scaling up multiple new formulations (from modeling through to production scale) is required
Experience in the following processes (at multiple scales) is required: Powder handling, filling, mixing, transport, isolation, polymer synthesis and reaction (more may be added)
Experience Design of Experiments (DOE) is required
Bachelor's degree in the following is required Chemical Engineering, Polymer Science, Polymer Engineering
Excellent communication, collaboration and influencing skills
Demonstrated ability to deliver project outcomes in an ambiguous environment
Requires experience managing self-directed work teams
Travel up to 20% may be required (domestic and international)
Preferred
Experience in biomaterials and material development highly preferred
Experience in Medical Device industry is preferred; experience in combination products is preferred. Experience with respect to PMA preferred
Proven problem-solving skills using analytical technologies is preferred
Experience in developing protocols and writing completion reports is preferred
Experience in vitro and ex vivo methods for characterizing prototypes and products is preferred
Advanced degree is highly preferred
Company
Katalyst CRO
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.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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