Katalyst CRO ยท 3 months ago
Senior Manufacturing Engineer
Bridgewater, NJ
Full-time
Onsite
Senior LevelKatalyst CRO is a company focused on shaping the future of diagnostic production processes. They are seeking a Senior Manufacturing Engineer to define equipment specifications, lead automation initiatives, and drive projects that enhance product quality and operational excellence.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Influence the design, scale-up, and optimization of manufacturing equipment
Lead cross-functional teams to deliver complex projects on time
Champion quality and compliance with cGMP and ISO standards
Work on cutting-edge packaging, micro dispensing, and automation system
Plan and manage filling/packaging projects, ensuring specs align with marketing goals
Create user requirements, bid packages, and validation protocols (IQ/OQ/PQ)
Reduce downtime and improve repair efficiency across equipment systems
Develop SOPs, records, and specifications to support manufacturing launches
Assess and implement quality and process improvements
Qualification
Required
Degree in Mechanical or related engineering field
Experience with cGMP manufacturing and automated filling/packaging systems
Knowledge of IQ/OQ/PQ validation and FDA compliance
Preferred
Background in material science, micro dispensing, or injection moulding a plus
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
Company data provided by crunchbase