Validation Engineer 2

Description

Veristas 500 experts team up with the worlds 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 worlds 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

Duties:

Independently understand clients quality standards cGMPs 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.

Requirements:

Bachelors degree in Mechanical Engineering or related field (or foreign degree equivalent) and at least 5 years of experience in position involving validation engineering. Alternative Requirements: Employer will also accept a Masters degree in Mechanical Engineering or related field (or foreign degree equivalent) and 2 years of experience in position involving validation engineering. Required Skills: 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.

Reports to Verista Inc. Headquarters in Fishers Indiana. Telecommuting permissible from home office anywhere in the U.S. Long term placement at unanticipated client sites in the U.S. possible.

Please Send Resumes to: HR Team

Benefits

Why Choose Verista

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life Short-Term and Long-Term Disability Insurance.
• Medical Dental & Vision insurances
• FSA DCARE Commuter Benefits
• Supplemental Life Hospital Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

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