*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.