Katalyst CRO · 3 months ago
Process/Validation Engineer
Branchburg, NJ
Full-time
Onsite
Mid Level
3+ years expKatalyst CRO is a company focused on engineering solutions in the medical device and pharmaceutical industries. They are seeking a Process/Validation Engineer responsible for providing engineering production support, implementing process improvements, and ensuring compliance with quality standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Process and Cleaning Validation Experience
Equipment Qualification (IOQ/PQ)
Quality System Experience (Veeva, Track wise, Compliance Wire)
Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years
Statistical Analysis (Minitab or JUMP)
The Process/Validation Engineer is responsible for providing engineering production support including:
Implementing process and technology improvements
Process and Cleaning Validation
Equipment Qualification
Collecting, monitoring, analysing, troubleshooting, and reporting manufacturing data related to performance in the areas of quality, cost, and speed/service to market
Investigating non-conformances, CAPAs, process performance drifts and implementing corrective and preventative actions
Responsible for the initiation and follow-through of the change control processes
Qualification
Required
Bachelor's degree in engineering, science or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3-5 years of significant process engineering and/or operational experience in Medical Device or Pharmaceutical industry
Experience with MS Office applications including Word, Excel & Outlook
Demonstrated understanding and use of statistical methods in experiment design and data analysis
Able to work independently and proactively in conjunction with all levels of the organization
Excellent Technical writing skills and attention to fine detail
Understanding of AATB, FDA, ISO, ISPE, and other regulatory guidelines including understanding of the various regulations and guidelines such as FDA 21 CFR 11, 820 and 1270, ISO 11737, 13485 and 14644, and others, as required
Six Sigma, Value Stream Mapping, Lean Manufacturing, Design for Manufacturability, DOE
Biological Products and aseptic processes
Development of robust manufacturing processes, validation, and process monitoring
Experience with root cause analysis methods
Experience with applications including Minitab or other statistical software, Client PowerPoint, Project, and Visio
Time management skills and follow-through skills with the ability to work on and manage multiple tasks with tight deadlines
Strategic thinking and planning
Excellent organizational skills
Excellent oral and written communication skills
Preferred
Medical Device with 3-5 Years
Additional post-graduate education may contribute towards the desired years of experience
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