Job Information
Digital Prospectors CSV Consultant in Portsmouth, New Hampshire
CSV Consultant
Portsmouth, NH
Job Type: Contract
Recruiter: Jaime Gunning (https://digitalprospectors.com/our-team/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.
Qualifications:
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.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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