CSV & CQV Engineer — Life Sciences Validation Leader

ADP, Inc.; Gurabo (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

JC Automation Corp. in Gurabo, Puerto Rico, seeks experienced CSV/CQV professionals to support a cGMP pharmaceutical manufacturing program.

You will author and execute validation deliverables, lead change control activities, perform Data Integrity assessments, and assist with commissioning and equipment qualification within a regulated quality system. The role requires a Bachelor's in engineering or life sciences, 2–4 years of CSV/CQV experience, and bilingual English/Spanish; you will

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 2–4 years of experience authoring and executing CSV or CQV deliverables in GMP pharma or biotech.
• Experience with full CSV lifecycle documents (URS, Design Specs, IQ/OQ/PQ, Traceability Matrix, Risk Assessment, Summary Reports).
• Bilingual in English and Spanish (oral and written).

Responsibilities

• Actively participate in team meetings to provide input on project timelines, activities, escalations, and task status.
• Execute CSV and CQV activities for computerized systems, facilities, and utilities, including validation plans and SOPs.
• Support commissioning and qualification activities for GMP facilities and utilities, including IQ/OQ/PQ documentation.
• Develop and revise controlled procedures in alignment with regulatory expectations and quality systems.
• Perform Data Integrity assessments and support remediation activities.

Skills

CSV/CQV deliverables

Data Integrity (ALCOA++)

Regulatory/compliance knowledge

Bilingual English/Spanish

Education

Bachelor's degree in Engineering or Life Sciences

Job description

JC Automation Corp. in Gurabo, Puerto Rico, seeks experienced CSV/CQV professionals to support a cGMP pharmaceutical manufacturing program.

You will author and execute validation deliverables, lead change control activities, perform Data Integrity assessments, and assist with commissioning and equipment qualification within a regulated quality system. The role requires a Bachelor's in engineering or life sciences, 2–4 years of CSV/CQV experience, and bilingual English/Spanish; you will