ZipRecruiter

Log In

Process/Validation Engineer

Process/Validation Engineer

Katalyst Healthcares & Life Sciences

Branchburg, NJ • On-site

Other

Posted 12 days ago

Job description

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.
Requirements:
  • 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. Additional post-graduate education may contribute towards the desired years of experience.
  • 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.
Katalyst Healthcares & Life Sciences logo

About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

Social media

FacebookTwitter

View All Katalyst Healthcares & Life Sciences Jobs

Apply

Most Popular Jobs Similar to Process Validation Engineer

Frequently asked questions

Q: What skills or qualities help someone succeed as a Process Validation Engineer?

A: To succeed as a Process Validation Engineer, key technical skills include proficiency in Good Manufacturing Practice (GMP) regulations, knowledge of validation methodologies (e.g., risk-based, design of experiments), and expertise in data analysis and statistical process control. Soft skills such as strong communication, problem-solving, and collaboration abilities are also crucial, as Process Validation Engineers must effectively interact with cross-functional teams, identify and mitigate risks, and document complex validation processes. By combining these technical and soft skills, Process Validation Engineers can ensure compliance, drive process improvements, and support the growth and success of their organizations.

Q: What is the career path for a Process Validation Engineer?

A: A Process Validation Engineer's typical career progression involves starting as an entry-level Validation Engineer, where they develop and implement validation protocols, and then advancing to a Senior Validation Engineer or Validation Lead, overseeing complex validation projects and teams. Mid-level roles, such as Validation Specialist or Technical Lead, often involve developing and maintaining validation standards, training junior engineers, and collaborating with cross-functional teams to ensure compliance. With experience and additional education, Process Validation Engineers can transition into senior leadership roles, such as Validation Manager or Director of Quality Assurance, or pursue specialized roles like Regulatory Affairs Specialist or Quality Engineer.

All JobsProcess Validation Engineer Jobs
Katalyst Healthcares & Life Sciences job posting for a Process/Validation Engineer in Branchburg, NJ with a salary of $25 to $56 Hourly with a map of Branchburg location.