Senior Validations Engineer

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

At Kelly ® Engineering we’re passionate about helping you find a job that works for you. How about this one?

We’re seeking Senior Validations Engineer to work for one of our top Biotechnology Industry client 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 following requirements

• 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 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.

The Senior 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.

Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affluent Reference. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.