CQV Engineer: Pharma Packaging & Equipment Validation

Arcadis; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Arcadis seeks a Qualification Support Specialist to support commissioning, qualification, and validation for packaging and related laboratory equipment at a pharmaceutical site in Durham, NC. You will author and execute qualification documents, coordinate results, and ensure GMP-aligned strategies.

Ideal candidates have hands-on CQV experience in pharma/life sciences, strong technical writing, and stakeholder management. On-site work with potential seven-day schedules to meet milestones.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline preferred or equivalent CQV/validation experience.
• Experience supporting commissioning, qualification and validation activities in pharma, biotech, or life sciences environments.
• Hands-on experience with packaging and laboratory equipment and computerized validation principles.
• Experience authoring GMP qualification documentation including risk assessments, protocols, reports, and deviation support.
• Experience with packaging systems (autoinjector, needle safety device, cartoning, serialization, case packing, palletizing, stoppering, leak testing, lab instrumentation).
• Experience using KNEAT or similar electronic validation lifecycle systems is strongly preferred.

Responsibilities

• Provide commissioning, qualification, and validation support for packaging and laboratory equipment.
• Author, review, and execute qualification lifecycle documents (URS, FAT, plans, specs, reports, deviation docs).
• Coordinate and document results, investigate discrepancies, support deviations to closure.
• Ensure alignment of design specs and qualification strategy with GMP and project standards.
• Collaborate with client team, validation management, engineering, manufacturing, quality, vendors and stakeholders.
• Attend project meetings, review documents, schedules, risks, and readiness; track milestones.
• Prepare weekly progress updates with deliverables, schedule status, risks, and a two-week look ahead.
• Other duties as assigned.

Skills

CQV experience

Technical writing

Stakeholder management

Communication

GMP understanding

Education

Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences

Tools

KNEAT

Job description

Arcadis seeks a Qualification Support Specialist to support commissioning, qualification, and validation for packaging and related laboratory equipment at a pharmaceutical site in Durham, NC. You will author and execute qualification documents, coordinate results, and ensure GMP-aligned strategies.

Ideal candidates have hands-on CQV experience in pharma/life sciences, strong technical writing, and stakeholder management. On-site work with potential seven-day schedules to meet milestones.