Verista, Inc. - Validation Engineer 2
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. Alternative Requirements: Employer will also accept a Master’s 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 [email protected] • [email protected] • For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
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.
Benefits
• 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 • Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. • For more information about our company, please visit us at Verista.com
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