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Pharmaceutical Validation Remote Jobs in Puerto Rico

Kelly Services

Senior Validations Engineer

Juncos, PR · On-site +1

$45/hr

Administrative shift (support a 24/7 manufacturing operations, some remote work is possible) Why ... Experience authoring, reviewing, and approving qualification protocols, validation reports, and ...

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Pharmaceutical Validation Remote information

What does a pharmaceutical validation remote professional do?

A Pharmaceutical Validation Remote professional is responsible for ensuring that pharmaceutical processes, equipment, and systems meet regulatory standards and operate as intended, all while working remotely. They review documentation, analyze data, and develop validation protocols to confirm compliance with industry guidelines such as Good Manufacturing Practice (GMP). Their work helps guarantee the safety, quality, and efficacy of pharmaceutical products, even though they complete most tasks off-site using digital collaboration tools. This role often involves coordinating with on-site teams, writing reports, and keeping up-to-date with changing regulations.

What are some typical challenges faced by professionals in remote pharmaceutical validation roles, and how can they be managed?

Remote pharmaceutical validation professionals often encounter challenges such as coordinating with cross-functional teams across different time zones, ensuring secure access to validation documentation, and maintaining clear communication during complex validation processes. To manage these, leveraging robust collaboration tools, establishing regular virtual check-ins, and adhering to strict documentation protocols are crucial. Proactively addressing potential gaps in remote communication and staying updated with regulatory guidelines can also help maintain validation quality and compliance.

What are the key skills and qualifications needed to thrive as a pharmaceutical validation specialist (remote), and why are they important?

To thrive as a Pharmaceutical Validation Specialist (Remote), you need expertise in validation protocols, regulatory compliance (such as FDA or EMA standards), and a background in pharmaceutical sciences or engineering. Familiarity with validation lifecycle documentation, quality management systems (QMS), and software like TrackWise or Veeva Vault is typically required. Strong analytical thinking, attention to detail, and effective remote communication are crucial soft skills for this role. These competencies ensure that pharmaceutical products and processes meet strict regulatory standards, safeguarding patient safety and product quality.

What are popular job titles related to Pharmaceutical Validation Remote jobs in Puerto Rico?

For Pharmaceutical Validation Remote jobs in Puerto Rico, the most frequently searched job titles are:

What job categories do people searching Pharmaceutical Validation Remote jobs in Puerto Rico look for?

The top searched job categories for Pharmaceutical Validation Remote jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Pharmaceutical Validation Remote jobs?

Cities in Puerto Rico with the most Pharmaceutical Validation Remote job openings:

Pharmaceutical Validation Remote jobs near you

Senior Validations Engineer

Kelly Services

Juncos, PR • On-site, Remote

$45/hr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 12 days ago

Key responsibilities

  • Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.

  • Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.

  • Author, review, and approve qualification protocols (IQ, OQ, PQ).

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)
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) strategies, planning, scheduling, and resource management in GMP environments.
  • Strong expertise in FAT, SAT, startup, field commissioning, and IQ/OQ/PQ execution.
  • Knowledge of ASTM E2500, ISPE guidance, risk assessments, and qualification lifecycle management.
  • Experience authoring, reviewing, and approving qualification protocols, validation reports, and technical documentation.
  • Strong understanding of GMP, FDA/EMA regulations, Data Integrity (ALCOA+), Change Controls, Deviations, and CAPA. 
  • Experience developing and executing process characterization studies, with strong technical writing, leadership, and project management skills.
  • Proficient in data analysis and strong technical writing skills in English and Spanish.
The Senior Validations Engineer will be responsible for; C&Q Strategy & Planning: Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. Commissioning Activities: Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning. Qualification Execution (IQ/OQ/PQ): Author, review, and approve qualification protocols (IQ, OQ, PQ). Documentation & Compliance: Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal company standards. Risk Management & Change Control: Lead and document risk assessments related to system qualification. Evaluate and manage change controls impacting validated systems. Assess impact of deviations and implement corrective and preventive actions (CAPA). Cross-functional Coordination: Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams. Characterization Process: Develop the characterization protocols. Execute the characterization activities. Develop and review the characterization reports

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
 


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 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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