[Hiring] Validation Engineer 2 @Verista

Role Description

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.
• 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.

Qualifications

• 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.

Requirements

• 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.

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.