Lead CSV Engineer/Analyst

6 days ago

New Brunswick, New Jersey, United States Verista Full time
Job Title: Lead CSV Engineer/Analyst

Verista is seeking a highly skilled Lead CSV Engineer/Analyst to join our team. As a key member of our automation team, you will be responsible for authoring, editing, and executing technical commissioning, qualification, and validation documentation for standard equipment, systems, and software.

Responsibilities:
  • Authoring, editing, and executing technical commissioning, qualification, and validation documentation for standard equipment, systems, and software.
  • Running test scripts and documenting results.
  • Adhering to project schedules for all assigned activities.
  • Maintaining clear, detailed records of 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.
  • General understanding of capital equipment implementation and process knowledge.
  • Understanding validation documents, URS, IQ, OQ, PQ.
  • Develop and execute protocols for automation systems including DeltaV, BMS, BAS, and EMS.
  • Perform CSV for production equipment and analytical instruments.
  • Collaborate with engineering and CQV teams to align automation validation activities with project timelines.
  • Conduct risk assessments and implement mitigation strategies for computerized systems.
  • Oversee documentation lifecycle for CSV activities, ensuring compliance with regulatory standards.
Requirements:
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • 10+ years of experience in automation and CSV within the pharmaceutical industry.
  • Expertise in DeltaV, Building Management Systems (BMS), BAS, and Environmental Monitoring Systems (EMS).
  • Strong knowledge of GAMP5, FDA regulations, and 21 CFR Part 11.
  • Excellent technical documentation and project management skills.
  • Experience in qualifying 'first in kind' equipment.
  • Experience with Robotic arms and processing.
  • 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.
  • Strong problem-solving and critical thinking skills.
  • 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.

Verista is an equal opportunity employer.

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