Senior Validation Engineer - GMP, CQV & QA Leader

Mykelly; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Biweekly direct deposit

Training resources

Vacation and holidays

Christmas bonus eligibility

Job summary

AtKelly Engineering in Juncos, Puerto Rico, is seeking a Senior Validations Engineer to lead commissioning, qualification, and validation initiatives for pharmaceutical manufacturing systems, equipment, and facilities. The role supports 24/7 operations with some remote work possible and offers a competitive W-2 compensation of $45.00 per hour.

The position is onsite at Juncos, PR, with responsibilities including strategy development, schedule planning, FAT/SAT execution, and data integrity

Qualifications

• MS degree in Engineering and 2 years of directly related experience OR BS degree in Engineering and 4 years of directly related experience in pharmaceutical, biotechnology, or other regulated manufacturing industries.
• Experience leading Commissioning & Qualification (C&Q) activities, including strategy development, planning, scheduling, and resource management for parenteral manufacturing processes, vision systems, device assembly, and packaging equipment (automatic and HMLV lines).
• Strong expertise in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), startup, field commissioning, and IQ/OQ/PQ protocol execution
• Working knowledge of ISPE guidance, risk assessment methodologies, and qualification lifecycle management
• Strong understanding of validation lifecycle activities, including protocol development and execution, GMP compliance, FDA/EMA regulations, Data Integrity, Change Control, Deviations, and CAPA management
• Proficiency in data analysis and technical report writing, with excellent verbal and written communication skills in both English and Spanish.

Responsibilities

• Lead complex validation initiatives for pharmaceutical manufacturing systems, equipment, and facilities.
• Provide technical expertise in process optimization, troubleshooting, and capital projects while ensuring GMP compliance.

Skills

Bilingual communication

Data analysis

Technical report writing

Education

MS in Engineering

BS in Engineering

Tools

IQ/OQ/PQ protocol execution

FAT/SAT

Job description

AtKelly Engineering in Juncos, Puerto Rico, is seeking a Senior Validations Engineer to lead commissioning, qualification, and validation initiatives for pharmaceutical manufacturing systems, equipment, and facilities. The role supports 24/7 operations with some remote work possible and offers a competitive W-2 compensation of $45.00 per hour.

The position is onsite at Juncos, PR, with responsibilities including strategy development, schedule planning, FAT/SAT execution, and data integrity