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)

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**​

Project Engineer / Facilities Process Engineer

(PR West)

The Project Engineer will support facilities and CAPEX projects, including HVAC systems, compressed air, utilities, and building automation systems. This role requires strong experience in facilities validation within regulated environments (Pharma, Biotech, or Medical Devices), with hands-on involvement in protocol generation and execution. The position is on-site in Añasco (M–F) with availability for weekends/OT as needed during testing phases.


Key Requirements:

  • Bachelor’s Degree in Engineering
  • Minimum of 6+ years of experience in Pharma, Biotech, or Medical Devices
  • Strong experience in Facilities and Utilities Validation
  • Hands-on experience with protocol writing and execution (FAT/SAT, IQ/OQ/PQ)
  • Experience with HVAC systems, compressed air systems, and utilities
  • Computer System Validation (CSV) experience, particularly with Building Automation Systems
  • Knowledge of regulatory requirements (FDA, GMP, ISO, GAMP 5)
  • Experience with CAPA, deviations, and non-conformance investigations
  • Strong project management and technical writing skills

Key Responsibilities:

  • Support facilities validation activities for CAPEX projects, including HVAC, compressed air, and utilities systems Generate, execute, and review validation documentation (URS, FRS, SDS, FAT/SAT, IQ/OQ/PQ, reports)
  • Participate in the full validation lifecycle, including risk assessments, traceability matrix, and deviation management
  • Lead and support non-conformance investigations and CAPA activities
  • Perform statistical analysis and develop sampling plans to support validation efforts
  • Troubleshoot automation and computer systems during validation activities
  • Coordinate with vendors and cross-functional teams for equipment installation and project execution
  • Ensure compliance with FDA, ISO, GMP, and other applicable regulations
  • Support audits, regulatory submissions, and continuous improvement initiatives
  • Monitor validation activities and report project status to ensure timely completion


Purchasing Agent

(PR -East)​​​
The Purchasing Agent supports procurement activities by managing purchasing processes, resolving invoice discrepancies, and coordinating with suppliers and internal teams to ensure accurate and timely transactions.
Key Responsibilities:

  • Serve as the main point of contact for reviewing and resolving invoice discrepancies.
  • Manage Credit Hold and Shipment Hold requests through ServiceNow or similar systems.
  • Process price change requests when discrepancies exist between Purchase Orders and invoices.
  • Collaborate with Supply Chain Planners/Buyers to resolve issues efficiently.
  • Review supplier statements of account and communicate updates directly with vendors, including regular follow-ups as needed.
  • Work closely with Accounts Payable to ensure timely processing and release of payments.

Qualifications:

  • Bachelor’s degree required (Supply Chain, Business, or related field preferred experience is most critical).
  • Experience in purchasing/buying roles. SAP or ERP system experience required. Strong experience handling invoice discrepancies.
  • Fluent in English (speaking, reading, and writing).


IT Tech

(PR -South)

​​​Key Responsibilities:

  • Develop, document, and configure system specifications aligned with architecture standards and business needs.
  • Support system planning and deployment, ensuring compliance with hardware, software, and security standards.
  • Evaluate and optimize system performance, including hardware/software integration and overall functionality.
  • Identify system issues, implement improvements, and test solutions to ensure data integrity and efficient performance.
  • Maintain documentation for system updates, configurations, and testing activities.
  • Act as a liaison between internal teams and technology vendors.

Technical Functions:

  • Design technology solutions based on business and user needs.
  • Assess whether standard platform capabilities meet requirements or if customization is needed.
  • Gather and prioritize integration requirements.
  • Perform system testing to ensure quality and performance.
  • Execute basic maintenance and performance optimization across operating systems.


Scheduler

(PR- West)

Requirements:

  • Experience in the Medical Device industry.
  • Proficiency in Microsoft Project and Primavera.
  • Strong experience managing and integrating complex project timelines.
  • Ability to identify and track risks, dependencies, interdependencies, and critical paths.

Responsibilities:

  • Develop, maintain, and update detailed project schedules.Integrate multiple project timelines to ensure alignment across functions.
  • Monitor project progress and identify potential risks or delays.
  • Analyze critical paths and recommend actions to keep projects on track.
  • Collaborate with cross-functional teams to ensure schedule accuracy and execution.


Microbiologist Steriliz

(PR East)

Schedule: Tuesday to Saturday | 1:00 PM – 10:00 PM

Requirements:

  • Bachelor’s Degree in Science (Microbiology or Biology preferred).
  • 3–5 years of experience in the Medical Device industry.
  • Strong knowledge of microbiology and sterilization processes.
  • Experience with testing bench, bioburden, and endotoxins (LAL).
  • Fully bilingual (English/Spanish).
  • Experience with Non-Conformance investigations.
  • Knowledge of Sterility Assessment.

Responsibilities:

  • Perform microbiological, chemical, and biological testing on raw materials, in-process, and finished products.
  • Prepare, clean, disinfect, and sterilize instruments, materials, and supplies.
  • Follow established protocols and regulatory requirements for handling and testing.
  • Analyze and interpret test results, ensuring accuracy and compliance with specifications.
  • Recommend and implement corrective actions when needed.
  • Develop, validate, and improve controlled environment and analytical methods.
  • Utilize standard and advanced laboratory instrumentation for qualitative and quantitative analysis.
  • Support method transfers from R&D when applicable.

Process Engineer / Product Engineer / Process Development

(PR East/ PR North)

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- West / PR -East / PR South)​​​

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 / Quality Application Specialist

(PR East- PR South- PR North) ​

The Quality Engineer and Quality Application Specialist 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)​

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.​



BE PART OF THE EQVAL WORK TEAM!

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