Lead CQV Engineer

LS Solutions; Scarborough (ME); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a talented Validation/CSV/CQV Developer/Automation Engineer to join their dynamic team. In this role, you will manage multiple projects, ensuring compliance and quality in a fast-paced environment. Your expertise in Commissioning & Validation will be crucial as you engage with clients, lead engineering studies, and maintain meticulous documentation. This opportunity offers a chance to work on impactful projects within the pharmaceutical and medical sectors, where your contributions will drive significant advancements. If you are looking for a challenging role that values your experience and skills, this is the perfect fit for you.

Qualifications

• Experience in Commissioning & Validation activities covering URS (GMP equipment).
• Proven ability to author and execute FAT, SAT, IOQ, CSV Protocols.

Responsibilities

• Manage multiple projects and act as the client-facing leader.
• Design and execute engineering studies and document results.
• Maintain detailed records for compliance audits.

Skills

Commissioning & Validation

Technical Documentation

Interpersonal Skills

Attention to Detail

Communication Skills

Education

10+ years of experience in CQV/CSV

GMP and Good Documentation Practice training

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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Hiring Top Talent!! (Validation/CSV/CQV/MES Developer/Automation Engineer/Project Manager All over the US) - Pharmaceutical/Medical…

• Managing the responsibilities on multiple simultaneous projects and/or clients
• Driving the activities as client facing leader and responsible party
• Act as the defined point of escalation and issue management on client projects
• Designing and executing engineering studies for critical process parameter definition and verification prior to validation
• Verifying system drawings including ability to review and as built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer
• Conducting and documenting 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
• Fluent in working with equipment OEMs and installation vendors
• Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed records qualification and validation
• Documenting impact and risk assessments as part of a team
• Completing user interface testing, software verification, and complete alarm testing on automated systems
• Developing, reviewing, and executing testing documentation
• Making recommendations for design or process modification based on test results when executing test scripts
• General understanding of capital equipment implementation and process knowledge

Requirements:

• Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)
• Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV Protocols
• Must meet onsite work requirements in Rahway, NJ
• 10+ years of demonstrated CQV/CSV experience in GMP regulated environments
• 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
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship
• GMP and Good Documentation Practice training (may be completed at onboarding)
• 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

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering and Information Technology

Industries

Business Consulting and Services