Senior Validations Engineer – Biotech GMP Leader (Onsite PR)

Kelly Services; Juncos (PR); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Biweekly direct deposit (W-2)

Paid vacation, sick leave, holidays, &

Christmas bonus eligibility

Job summary

Kelly Services is seeking a Senior Validations Engineer for an onsite role in Juncos, PR. The position focuses on commissioning, qualification, and validation across parenteral manufacturing lines, with emphasis on GMP, IQ/OQ/PQ, and regulatory compliance.

Bilingual English/Spanish capability is required for cross-functional collaboration. The role involves leading FAT/SAT, risk assessment, and lifecycle management while ensuring data integrity and robust documentation.

Qualifications

• MS degree in Engineering with 2+ years of related experience or BS degree in Engineering with 4+ years in pharma/biotech or regulated manufacturing.
• Experience leading Commissioning & Qualification (C&Q) activities, including strategy, planning, scheduling, and resource management for parenteral processes, vision systems, device assembly, and packaging lines.
• Expertise in FAT, 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 GMP, FDA/EMA regulations, Data Integrity, Change Control, Deviations, and CAPA management.
• Proficiency in data analysis and technical report writing, with excellent English and Spanish communication.

Responsibilities

• Lead complex engineering, commissioning, qualification, and validation initiatives for manufacturing systems, equipment, and facilities.
• Provide technical expertise in process optimization, troubleshooting, and capital projects while ensuring GMP and validation compliance.
• Collaborate with cross-functional teams to deliver high-quality, compliant solutions that support operational excellence and new product introductions.

Skills

C&Q leadership

FAT/SAT/IQ/PQ

GMP compliance

FDA/EMA regs

Data analysis

Technical report writing

English/Spanish comms

Education

MS Eng. + 2 years OR BS Eng. + 4 years (pharma/reg.)

Job description

Kelly Services is seeking a Senior Validations Engineer for an onsite role in Juncos, PR. The position focuses on commissioning, qualification, and validation across parenteral manufacturing lines, with emphasis on GMP, IQ/OQ/PQ, and regulatory compliance.

Bilingual English/Spanish capability is required for cross-functional collaboration. The role involves leading FAT/SAT, risk assessment, and lifecycle management while ensuring data integrity and robust documentation.