CSV Consultant
Portsmouth, NH
Job Type: Contract | Recruiter: Jaime Gunning | Phone: 617.215.7066
Position: CSV Consultant
Location: Portsmouth, NH (Onsite)
Length: 6+ months
Covid Requirements: N/A
Job Description:
Our client is looking for a CSV Consultant to join their growing team.
Essential Duties and Responsibilities (but not limited to):
- Manage and plan the work of the computerized system validation project team.
- Assess workload and communicate resource requirements to achieve validation goals to the project leads and CSV manager.
- Manage and track execution of validation activities versus project timelines.
- Work closely with project teams (i.e., scheduling, SMEs, SOs, BPOs) to ensure acceptance criterions are met from a CSV standpoint in each project phase gate.
- Identify efficiency and process improvements to better streamline the CSV validation strategy and approach.
- Document and work to apply lessons learned as we proceed with the system validation as part of Project Lynx.
- Plan and adhere to the computer validation master plan, validation protocols, and project plans.
- Review and approve completed protocols and reports for completeness, cGMP compliance, and acceptability of data as needed.
- Develop, train, coach, and mentor CSV consultants on the validation team in areas of technical expertise, task management, and leadership.
- Present and defend the computer systems validation program and acceptance criteria to cross-functional teams and stakeholders.
- Review and suggest revisions of the Validation Master Plan as necessary to ensure GMP compliance with applicable regulations, guidelines, and best practices.
- Show smart learning capabilities to learn and utilize Kneat application for paperless testing and SDLC documentation as part of the project.
- Perform other project and CSV lead duties as assigned.
- Bachelor’s degree in Industrial Engineering, Pharmaceuticals, Industrial Production Processes, Pharmaceutical Engineering, or Industrial Design.
- 5+ years of experience in CSV and automation.
- Strong implementation and validation experience in PCS (DeltaV), BAS (Rockwell), MES (Syncade), and Pi Historian.
- Ability to work both independently and in a team-oriented, collaborative environment is essential.
- Strong verbal and written communication skills.
- Prior DeltaV software development and testing experience is a plus.
- Experience authoring and testing MES Recipe is a plus.
- Strong knowledge of SDLC regulations including 21CFR part 11, Annex 11, and computer systems validation requirements.
- Prior experience with Kneat is strongly preferred.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
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