Validation Engineer / Specialist
EQVAL Group, Inc • Ponce, Puerto Rico
**Role & seniority: ** Validation Engineer/Specialist (seniority not explicitly stated; mid-level implied by “experienced” requirements)
**Stack/tools: **
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Validation documentation/protocols (Validation Plans, IQ/OQ/PQ, URS/FRS, reports)
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Measurement System Analysis (MSA): Attribute Analysis, GR&R, DOEs
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Minitab (statistical tool)
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Top 3 responsibilities:
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Support Validation/Qualification activities in Medical Devices or Pharmaceutical manufacturing
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Develop and execute validation documentation (plans/protocols/assessments/reports) including IQ/OQ/PQ
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Perform MSA work (GR&R, attribute analysis, DOEs) and support statistical analysis (Minitab)
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Must-have skills:
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Bachelor’s degree in an engineering field
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Hands-on experience with validation documentation and execution (URS/FRS, IQ/OQ/PQ, reports)
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MSA experience (Attribute Analysis, GR&R, DOEs)
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Proficiency with Minitab
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Strong technical writing
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Bilingual: English & Spanish; strong written/spoken communication
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Nice-to-haves:
- Not specified in the provided text (benefits include training/certifications via EQVAL Academy)
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Location & work type:
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Puerto Rico
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Full-time, 100% on-site
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Full Description
EQVAL Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others). We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.
The Validation Engineer/Specialist is required to support Validation/Qualification activities in a Medical Devices or Pharmaceutical manufacturing environment.
Minimum Requirements
Bachelor’s degree in an Engineering field.
Experienced in the development and execution of validation documentation and protocols, including Validation Assessments, Validation Plans, Requirements Specifications (URS, FRS), IQ, OQ, PQ and Reports.
Experience developing and implementing Measurement System Analysis (MSA), including Attribute Analysis, GR&R, DOEs.
Experience in Minitab (software statistical tool).
Good technical writing skills.
Fully bilingual (English and Spanish) with exceptional communication skills, both spoken and written.
Benefits
Health insurance (Medical, Dental, Vision, Pharmacy)
Life Insurance
Paid time off (PTO)
Holidays
Professional Growth (Courses and Certifications by EQVAL Academy)
Referral program
Productivity incentive
*This position will be full-time 100% on site in Puerto Rico.
We offer competitive compensation, benefits, and opportunities for career growth. If you are a motivated individual with passion, we would love to hear from you. Apply now!!
EQVAL Group is an EEO. We comply with all federal, local, and state laws regarding non-discrimination.
