Senior CQV Engineer – Pharma Equipment Validation

Veristainc; Bloomington (IN); On-site; USD 79,000 - 123,000; Full time

Benefits offered by this job

Competitive pay

401(k) with employer match

Medical, Dental & Vision insurance

Paid Time Off

Tuition Reimbursement

Team Social Activities

Job summary

Verista in Bloomington, IN is seeking a Senior CQV Engineer to provide engineering and CQV support for manufacturing equipment and systems throughout design, installation, commissioning, startup, and qualification. You will develop an understanding of equipment design, controls, and operating principles, serving as a technical resource across project phases.

You will collaborate with vendors, engineering, manufacturing, automation, quality, and other stakeholders, and author CQV documentation

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 5+ years in engineering, commissioning, qualification, or validation in regulated environments.
• Ability to read and interpret engineering drawings, P&IDs, and specs.
• Knowledge of CQV lifecycle activities including FAT, SAT, IQ, OQ, and PQ.

Responsibilities

• Provide engineering and CQV support for installation, start-up, and qualification of manufacturing equipment and systems.
• Develop understanding of equipment design, controls, and operating principles.
• Serve as technical resource for equipment-related issues across project phases.
• Review drawings and vendor documentation to ensure qualification requirements are met.
• Coordinate with vendors,Engineering, Manufacturing, Automation, Quality and other stakeholders.
• Author, review, and revise CQV and engineering docs (URS, protocols, IQ/OQ/PQ, risk assessments, deviations).
• Ensure CQV activities are documented per project requirements and cGMP expectations.
• Manage assigned activities against schedules and communicate risks and progress.
• Provide hands-on support in the field during installation, startup, testing, and qualification.
• Investigate and resolve issues during commissioning and qualification.

Skills

Bachelor's degree

CQV experience

Reading drawings

CQV lifecycle knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Verista in Bloomington, IN is seeking a Senior CQV Engineer to provide engineering and CQV support for manufacturing equipment and systems throughout design, installation, commissioning, startup, and qualification. You will develop an understanding of equipment design, controls, and operating principles, serving as a technical resource across project phases.

You will collaborate with vendors, engineering, manufacturing, automation, quality, and other stakeholders, and author CQV documentation