Come share the
EQVAL experience!



"Professional working environments, with the personal and professional treat that only EQVAL brings to consultants and employees!"
​We are currently looking for professionals able to serve and share our Company Mission, for the following LONG-TERM OPPORTUNITIES in Puerto Rico. (Full Time Employees and/or Professional Services contracts):​


Engineering Technician

(PR East- PR North)

We are seeking an Engineering Technician to join EQVAL Group, Inc. This position plays a vital role in supporting engineering projects within a medical devices manufacturing environment.

Responsibilities:

  • Exposure to manufacturing or assembly operations industries, medical devices preferred.
  • Conduct data collection and analysis to support project objectives.
  • Work with logic controllers (PLC, HMI) and schematics to troubleshoot and optimize systems.
  • Fabricate and assemble components or fixtures, as required for manufacturing operations or engineering projects.
  • Utilize hand tools effectively to carry out engineering tasks.
  • Participate in project scheduling and coordination with engineering and manufacturing team members.
  • Ensure compliance with industry standards and regulations throughout project phases.

Requirements:

  • Associate Degree in Engineering Technology or related field.
  • Available for different shifts (1st, 2nd, 3rd), including nights and weekends
  • Good mathematical skills to support engineering calculations.
  • Familiar with logic controllers (PLC, HMI, Computers) is highly desirable.Familiarity with hand tools is a plus.
  • Excellent communication skills for effective collaboration within teams.
  • **ALL SHIFTS**


EHS Specialist

(PR East)

The EHS Specialist will support EHS Programs and provide Regulatory Expertise within the Medical Device industry.

Requirements:

  • EHS Programs and Regulatory Expertise.
  • Minimum of 4 years of proven experience managing EHS functions.
  • Experience supporting manufacturing operations, preferably with programs such as LOTO, Electrical Safety, and Waste Management.
  • Strong knowledge of OSHA, EPA, DOT, and local environmental regulations applicable to medical device manufacturing.
  • Experience conducting risk assessments, ergonomic evaluations, and safety audits in controlled environments.
  • Proven ability to implement Corrective and Preventive Actions (CAPA) to address EHS findings.
  • Leadership in Safety Culture and Continuous Improvement.
  • Demonstrated success driving proactive safety initiatives and leading cross-functional EHS programs.
  • Experience delivering EHS training, coaching, and influencing leadership at all organizational levels.
  • Ability to use data-driven insights to enhance environmental performance and employee safety engagement.

Education Required:

Bachelor’s degree in Science, Engineering, or a related field.

Responsibilities:

  • Develops, administers, and implements environmental programs in compliance with governmental regulations.
  • May oversee pollution prevention, compliance monitoring, and auditing activities.
  • Prepares environmental impact reports for new construction projects, plant processes, and permit modifications.
  • Reviews and analyzes environmental documentation issued by regulatory agencies.
  • Evaluates proposed regulations to determine financial, operational, and environmental impacts.
  • Works with federal, state, and local regulators to resolve compliance issues, establish permit requirements, and support audits.
  • Represents the company in government and industry rulemaking activities.
  • Ensures timely corrective actions where environmental, health, or safety risks are identified.
  • Promotes employee awareness and provides training on environmental, health, and safety matters.

Microbiologist

(PR East)

The Microbiologist will support microbiological testing, environmental monitoring, and sterilization validation activities within a Medical Devices manufacturing environment. This role involves ensuring compliance with regulatory standards, conducting essential laboratory testing, and maintaining accurate documentation to ensure product quality and safety.


Minimum Requirements:

  • Bachelor’s Degree in Microbiology or related field.
  • Experience in microbiological analysis/testing in the pharmaceutical or medical device industry.
  • Proficiency in SOP development and technical writing.
  • Fully bilingual in English and Spanish.
  • Availability to work 1st and 2nd shift

Key Responsibilities:

  • Microbiological Testing: Conduct tests (bioburden, endotoxin, sterility) on raw, in-process, and finished products.
  • Environmental Monitoring: Perform microbial testing in clean rooms and production areas to ensure compliance.
  • Sterilization Validation: Support sterilization processes, including microbial challenge studies and review of validation data.
  • SOPs & Documentation: Create and update Standard Operating Procedures (SOPs), and ensure all lab documentation is GMP-compliant.
  • Bench Work & Process Improvement: Apply hands-on experience in bench work, observe processes, and recommend improvements.
  • Autoclave Operations: Operate autoclaves for sterilization and equipment preparation.
  • Knowledgeable of the industry standards and regulations, such as ISO, FDA, GMP, or GLP.
  • Project management skills required.
  • Fully bilingual (English and Spanish).
  • Good technical writing skills.
  • Interact with cross functional departments to obtain validation data.


Buyer/Purchasing Agent

(PR East-South)

The Buyer/Purchasing Agent will coordinate price change processes, ensuring timely updates to prices, payment terms, and Incoterms in a Medical Device Manufacturing environment. This role requires purchasing experience, SAP proficiency, and strong customer service skills to work independently and collaborate with suppliers and stakeholders. Minimum Requirements:


  • Bachelor’s degree in Business, Supply Chain, or related field.
  • Minimum of 2 years of experience in purchasing or buyer roles.
  • SAP/ERP System Experience
  • Strong customer service orientation.
  • Invoice Issue Resolution.
  • Self-motivated with the ability to work independently.
  • Proficiency in Microsoft Office Suite (Excel, Power BI, Teams).
  • Strong organizational and communication skills.
  • Experience working with suppliers and internal stakeholders.

Responsibilities:

  • Serve as the point person and coordinator for the front-end price change process.
  • Receive, organize, and coordinate incoming requests via ServiceNow or other intake methods.
  • Assess initial intake requests to either deny or request completion of a formal price change intake form from the supplier.
  • Evaluate price change intake forms to ensure they meet established standards.
  • Enter supplier details into client's Price Change Tracker.
  • Coordinate with assigned approvers to ensure timely receipt of required information.
  • Manage and provide decisions for price change intake forms assigned to Shared Services.
  • For approved price changes, update part master data in applicable ERP systems and adjust open purchase orders based on effective dates.
  • Ensure clear and timely communication of price, payment term, and Incoterm changes to all relevant stakeholders.
  • Support process efficiency and continuous improvement in purchasing and supplier management operations.

​

Process Engineer

(PR East/ PR North)

The Process Engineer will support manufacturing operations on a Medical Device environment by ensuring equipment and processes meet quality and efficiency standards. This role requires expertise in validation, troubleshooting, and equipment commissioning, while collaborating with cross-functional teams to implement improvements and maintain regulatory compliance.
Minimum Requirements:

  • Bachelor’s degree in Engineering (required).
  • Minimum of 4 years of relevant experience, or advanced degree with at least 1 year of experience.
  • Proficiency in validation processes, including Process Validation (PV) and Computer System Validation (CSV).
  • Experience with change control in medical devices.
  • Experience in equipment commissioning and qualification.
  • Strong troubleshooting skills and experience with equipment setups.
  • Proficiency in document management.
  • Background in quality, process control, and assurance within the medical device industry.
  • Strong organizational, analytical, and communication skills.
  • Ability to work collaboratively with cross-functional teams.

Responsibilities:

  • Provide technical and sustaining engineering support in manufacturing operations.
  • Recommend and implement equipment and process modifications to meet quality standards, improve production efficiency, and increase yields.
  • Integrate equipment and material capabilities to meet process and technology specifications.
  • Review product development requirements for compatibility with processing methods, cost, and schedule considerations.
  • Collaborate with product design and development teams to ensure processes and designs are aligned.
  • Lead innovation, development, and optimization of manufacturing processes, from feasibility to implementation.
  • Conduct statistical analysis and ensure processes are compatible with statistical process control techniques.
  • Ensure compliance with industry regulations, validation protocols, and internal quality standards.


Validation Engineer / Specialist

(PR -East / PR South / PR North)​​​

Validation Engineer/Specialist is required to support Validation/Qualification activities in a Medical Devices manufacturing environment.

Minimum Requirements:

  • Bachelor Degree in Engineering Field (Mechanical, Electrical, Industrial Engineers preferred).
  • Knowledge in 21 CFR Part 820 regulation.
  • Experienced (3-5 years) 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.
  • Project management skills required.Fully bilingual (English and Spanish).
  • Experience in Minitab (software statistical tool).
  • Good technical writing skills. ​


Quality Engineer

(PR East-)​

The Quality Engineer will support manufacturing operations in a regulated medical device environment, with a primary focus on validations, investigations, and risk management activities. This role requires close collaboration with Engineering, Manufacturing, and Quality teams to ensure compliance, product quality, and the successful execution of projects aligned with regulatory standards.

Minimum Requirements:

  • Bachelor’s degree in Engineering (Mechanical, Electrical, or Chemical preferred)
  • 3–5 years of experience in Quality or Engineering (excluding laboratory) within a regulated industry.
  • Experience with risk management documentation (pFMEA)
  • Basic knowledge of statistics (Minitab)
  • Experience designing validation strategies (requirements flow-down from design to manufacturing)
  • Hands-on experience investigating manufacturing operations events to support product disposition.
  • Experience assessing and tracing manufacturing defect/reject trends.
  • Experience performing and/or reviewing process and equipment validations (URS, FAT, IQ, OQ, PQ, TMV) – excluding laboratory and cleaning.
  • Strong knowledge of medical device regulations (FDA, ISO 13485, EU MDR)
  • Experience with projects involving design requirements validation and manufacturing controls (not Operational Excellence initiatives)
  • Expertise in CAPA, investigations, root cause analyses, and technical writing.
  • Strong critical thinking and problem-solving skills with a focus on risk management (pFMEA).
  • Experience in process and computer system validations.

Responsibilities:

  • Lead and support nonconformance investigations, root cause analysis, and CAPA implementation.
  • Review and execute validation protocols for manufacturing processes and equipment (URS, FAT, IQ, OQ, PQ, TMV).
  • Analyze yield, defect, and trend data to identify quality issues and drive improvements.
  • Develop, assess, and maintain pFMEAs for suppliers and manufacturing processes.
  • Collaborate with cross-functional teams to ensure validation and risk management compliance throughout the product lifecycle.
  • Review, develop, and maintain quality documentation in alignment with regulatory and internal requirements.
  • Support projects involving design requirements validation, manufacturing controls, and process improvements.
  • Apply statistical methods (SPC, Minitab) to monitor and enhance product and process performance.
  • Investigate customer complaints, determine root causes, and recommend corrective actions.


Manufacturing Engineer

(PR East/ PR South/ PR North)​

The Manufacturing Engineer must have experience on Medical Device or Pharmaceutical industries, will focus on executing validation (IQ, OQ, PQ) and optimizing manufacturing processes. This role involves troubleshooting, improving production efficiency, and ensuring compliance with regulatory standards in a fast-paced environment.


Responsibilities:

  • Lead and execute validation activities for equipment and process changes, including IQ, OQ, PQ, and associated documentation.
  • Design and optimize manufacturing processes, ensuring efficient production layouts, material handling, and tool fabrication.
  • Troubleshoot and improve production equipment and processes to enhance operational efficiency and product quality.
  • Collaborate with cross-functional teams to support investigations (NCRs, Complaints) and implement corrective actions.
  • Ensure compliance with regulatory standards (cGMP) in all manufacturing processes and validation activities.

Minimum Requirements:

  • Bachelor’s degree in an Engineering field.
  • Proven experience in developing and executing validation documentation, including Validation Plans, URS, FRS, IQ, OQ, PQ, and related reports.
  • Hands-on experience in FDA inspections, ISO certifications, audits, and change control, non-conformance, and CAPA processes.
  • Strong knowledge and experience in cGMP for Medical Device manufacturing environments.
  • Proficiency in statistical analysis (GR&R) and data management, including tools like Minitab.
  • 1-3 years of experience in areas such as investigations (NCRs, Complaints, CAPA), Lean Manufacturing, and Six Sigma tools.
  • Experience with pFMEA (analysis and development) and its application.
  • Fully bilingual (English and Spanish) with exceptional communication skills, both spoken and written.
  • Expertise in Measurement System Analysis (MSA), including Attribute Analysis, GR&R, and Design of Experiments (DOE).
  • Proficient in Microsoft Word, Excel, PowerPoint, and Minitab.
  • Availability for 2nd shift and 3rd shift.

Personal Traits:

  • Highly motivated, self-starter with the ability to handle multiple tasks and meet deadlines.
  • A problem solver who thrives in a fast-paced, dynamic environment.
  • Excellent interpersonal skills with the ability to collaborate effectively across teams.​

CSV Engineer

(PR- East)

The Computer System Validation (CSV) Engineer will support the validation, testing, and documentation of computer systems to ensure compliance with regulatory and quality standards, collaborating with IT, quality, and operations teams to maintain validated systems and data integrity.

Requirements:

  • Education Required: Bachelor’s Degree in Engineering
  • Experience Required: 4-6 years in regulated environments
  • Must be Bilingual: Spanish/English Computer System Validation (CSV) and IT systems knowledge in regulated environments.
  • Experience preparing and managing validation documentation, SOPs, and change controls.
  • Understanding of federal and international regulations governing computerized systems (e.g., FDA 21 CFR Part 11, ISO 13485, EU Annex 11).
  • Quality and compliance leadership, including guiding peers and cross-functional teams.


Key Responsibilities:

  • Conduct compliant validation processes for quality IT systems, including preparation of formal documentation such as SOPs, validation protocols, and reports.
  • Coordinate validation activities with clients, developers, IT personnel, and operational teams, both domestic and global if applicable. Identify requirements for compliant computerized operations and recommend implementation and maintenance of procedures to assure compliance.
  • Monitor regulatory changes and ensure validation practices remain up to date with federal and international requirements.
  • Perform system administration and configuration of quality IT systems.
  • Report on validation activity status to fulfill regulatory and internal quality requirements.
  • Support audits and regulatory inspections by ensuring all validated systems and documentation are compliant.

Calibration & Metrology Technician

(PR- East)

Turnos:

  • Primer turno: L–V, 7:00 a.m. – 3:30 p.m.
  • Segundo turno: L–V, 10:00 a.m. – 6:30 p.m.

Requisitos:

  • Grado asociado o técnico en Metrología, Calibración, Instrumentación, Tecnología de Ingeniería de Control de Calidad, Tecnología de Ingeniería Mecánica/Electrónica o áreas relacionadas.
  • Al menos un (1) año de experiencia en la industria de manufactura (Farmacéutica, Dispositivos Médicos o Biotecnología).
  • Conocimiento y experiencia en calibraciones e instrumentación.
  • Conocimiento y/o experiencia con SAP.
  • Experiencia en Microsoft Excel y Word.
  • Bilingüe (español e inglés).
  • Capacidad para aprender con rapidez y trabajar en equipo.


BE PART OF THE EQVAL WORK TEAM!

How to apply? Send your resume to info@eqvalpr.com