Senior Validations Engineer

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.

Apply to be Senior Validations Engineer today!

Recruiter: Lilly Abouomar 9395454792

#SETTPuertoRico #Kelly80

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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.

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