Validation Engineer – Level 2
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Job Description
Validation Engineer ensuring compliance with quality, cGMP, and regulatory standards for clients. Independently verify testing, conduct assessments, and support change management programs.
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.
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.
- 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
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