Senior Validation Engineer at LVI Associates

All applicants must be authorized to work in the United States. We are not currently accepting work visas.

Overview

Our client are looking for a Validation/Senior Validation Engineer for a position in Warren, NJ.

Please find details below:

Senior Validation Engineer Responsibilities:

• Develop, author, and execute commissioning and qualification (CQV) documentation for the Bulk CO2 Gas System, including protocols and reports (IQ, OQ, PQ).

• Collaborate with project teams to ensure successful installation, commissioning, and validation of the system.

• Coordinate and document gas sampling activities to validate system performance.

• Prepare and deliver high-quality, detailed documentation that aligns with cGMP standards and project requirements.

• Identify and address technical challenges during the commissioning and qualification phases.

• Maintain focus on documentation quality and accuracy throughout the project lifecycle.

• Ensure clear, detailed records of qualification and validation, and change control activities for future compliance audits.

• Author, edit, and execute technical commissioning, qualification, and validation documentation for standard equipment/systems/software, and processes as directed by the project leader.

• Run test scripts and document results.

• Adhere to the project schedule for all assigned activities.

• Maintain clear, detailed records of qualification and validation.

• Document impact and risk assessments as part of a team.

• Develop, review, and execute testing documentation.

• Make recommendations for design or process modification based on test results when executing test scripts.

Requirements:

• Must be willing to work onsite in Warren, NJ.

• Bachelor's Degree or equivalent required.

• 5+ years of experience in commissioning, qualification, and validation (CQV) activities in a regulated environment, with a focus on gas systems.

• Strong expertise in document authorship, including protocol development and final report writing.

• Hands-on experience with gas sampling coordination and system validation in cGMP environments.

• Comprehensive knowledge of cGMP regulations, validation guidelines, and quality management systems.

• Exceptional organizational, problem-solving, and communication skills.

• General understanding of capital equipment implementation and process knowledge.

• Ability to mentor and guide less experienced team members.

• Ability to communicate effectively with clients.

• Proven ability to identify areas of business expansion and report to the management team for follow-up.

• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.

• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization.

• Proficiency using PC and Microsoft Office tools.

• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.

• Ability to work as part of a team.

• Excellent organizational and time management skills.

• Strong attention to detail.

• GMP and Good Documentation Practice.

• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).

• Basic skills with EXCEL and PowerPoint.

• Strong interpersonal skills and clear communication capabilities.

• Experience with and tolerance for high levels of challenge and change.

• Experience in GMP regulated environment.

• Proven attention to detail and organization in project work.

• Capable of working on assigned tasks without mentorship.

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.