Senior Validations Engineer

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 we’re passionate about helping you find a job that works for you.

We’re seeking Senior Validations Engineer to work for one of our top BiotechnologyIndustryclient at Juncos, PR.

Salary:$45.00 hr – W2

Shift: Administrative shift(support a 24/7 manufacturing operations, some remote work is possible)

Location: Onsite position at Juncos Puerto Rico US

Why you should apply to be Senior Validations Engineer

• Competitive pay with biweekly direct deposit (W-2)
• Hands-on experience supporting critical manufacturing and quality systems in a leading biotechnology environment
• Collaborative, fast-paced, and dynamic workplace with growth opportunities
• Access to extensive training resources and career guidance
• Paid vacation, sick leave, holidays, and eligibility for a Christmas bonus(Must comply with minimum established requirements to qualify.)

This job might be an outstanding fit if you have the followingrequirements:

• MS degree in Engineering and 2years of directly related experience ORBS degree in Engineering and 4years of directly related experiencein pharmaceutical, biotechnology, or other regulated manufacturing industrie
• 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.

TheSenior Validations Engineer leads complex engineering, commissioning, qualification, and validation initiatives for pharmaceutical manufacturing systems, equipment, and facilities. This role provides technical expertise in process optimization, troubleshooting, and capital projects while ensuring compliance with GMP and validation requirements. The engineer collaborates with cross-functional teams to deliver high-quality solutions that support operational excellence and new product introductions.

Helping you discover what’s next in your career is what we’re all about, so let’s get to work.