CSV Engineer

Company: DPS Group Global
Location: Cambridge
Posted on: July 31, 2022

Job Description:

SummaryDPS Engineering is looking for a CSV Engineer to support a client in the Cambridge, MA area. The ideal candidate will be at a mid to senior experience level in the CSV domain within the pharmaceutical industry. The resource would have a strong knowledge base in network infrastructure, audit trail (part 11), and data integrity review.Key Responsibilities

• Represent CSV and participate/support the planning, generation, and execution of quality documentation
• (Including but not limited to IOQ protocols and reports, change controls and specifications) along with
• support of required review and approval cycles
• Provide input into authorship, revision, creation, support, and maintenance of CSV and IT-related SOPs,
• work instructions, and forms.
• Perform all tasks per clients VVS Standard Operating procedures and ensure training is complete
• on said procedures.
• Represent the client's VVS as a witness in third-party FAT/SAT execution activities.
• Partner with internal and external stakeholders during equipment and computer system implementation,
• support continuous improvement initiatives, and system lifecycle activities to ensure data integrity
• compliance is maintained.
• Perform Periodic Reviews of IT systems to ensure they are in a state of compliance per applicable
• Demonstrate and apply knowledge of agency regulations (e.g., FDA 21 CFR Part 210, 211, 820; EudraLex
• Annex 11, Disaster Recovery) and guidance (e.g., FDA, GPSV), and industry best practices (e.g., ISPE,
• GAMP 5).
• Maintain exceptional organization, commitment, keen interpersonal, and communication skills, as well as
• identify areas to enhance safety, innovation, and overall project optimization.Skills & Qualifications
  • The resource will be at a mid to senior experience level in the CSV domain within the pharmaceutical industry
  • The resource would have a strong knowledge base in network infrastructure, audit trail (part 11), and data integrity reviewThe CompanyDPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.

Keywords: DPS Group Global, Cambridge , CSV Engineer, Engineering , Cambridge, Massachusetts