Validation Engineer 2

Verista, Inc.•Fishers, IN

1d•$95,389 - $153,504•Remote

About The Position

Verista's 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Requirements

Bachelor’s degree in Mechanical Engineering or related field (or foreign degree equivalent) and at least 5 years of experience in position involving validation engineering.
Demonstrated ability with lab techniques and general lab analytical operations, and understanding of baseline lab standards and system suitability verification
Demonstrated ability with bench top analytical equipment and chromatography and LIMS system sample workflows
Demonstrated ability with IT system formats, configurations, and workflows
Demonstrated ability with business processes supporting one or more domains, such as: R&D, Clinical, Quality System Management, Supply Chain & Logistics or Commercialization
Demonstrated ability with system design and/or configuration activities
Demonstrated ability with complex automated lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators
Demonstrated ability with lab system configuration and operation
Demonstrated ability creating various dynamic and static data within a LIMS system
Demonstrated ability with methods and how to acquire, process and report in Empower
Demonstrated ability with system integrations, including how integrations are designed / constructed, data flow from source systems to target systems, typical testing approach for system integrations
Demonstrated ability providing technical guidance and mentorship to other team members
Demonstrated ability identifying areas of business expansion and report to management team for follow-up.

Nice To Haves

Master’s degree in Mechanical Engineering or related field (or foreign degree equivalent) and 2 years of experience in position involving validation engineering.

Responsibilities

Independently understand client’s quality standards, cGMP’s and regulatory standards to support team in compliance of validation effort.
Design validation plans.
Conduct independent verification of testing against specifications.
Conduct and document impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes.
Complete user interface testing, software verification, and complete alarm testing on automated systems.
Develop, review, and execute testing documentation.
Make recommendations for design or process modification based on test results when executing test scripts.
Work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities.
Includes ability to complete root cause analysis.
Support clients change management program – including author proposed changes, execute impact assessments/ regression analysis and support client documentation of change results and release.
Maintain (and ensure the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits.