"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):
EHS Specialist
(PR North- Manatí)
The EHS Specialist must have experience in the Medical Devices / Pharmaceutical industries. Must be experienced implementing and maintaining Safety policies and Procedures.
Minimum Requirements:
- Experience installing equipment in facilities and utilities department.
- Knowledge and experience to evaluate the applicability of any regulatory or corporate safety requirements.
- Knowledge and experience to implement any requirement, such as but not limited to the revision of OSHA safety programs, revision and approving internal security permits.
- Experience with HVAC systems and air compressors. (plus)
- University Degree and minimum of 2 years of relevant experience.
- Medical Device or Pharmaceutical experience.
- Bilingual (Spanish and English)
- Strong communication skills (oral and written)
Drafter (Engineer)
(PR West- San Germán/ Maricao)
The Drafter Engineer must have experience in the Medical Devices / Pharmaceutical industries.
- Technical College or Bachelor of Engineering (preferred)
- Experienced ( 1-3 years) previous experience in regulated industry (pharmaceutical and medical device).
- Pneumatic, electrical, and manufacturing equipment drawings.
- Knowledge of electronics and automation principles.
- Knowledge of blueprint reading, electrical, and pneumatic drawings.
- AutoCAD and SolidWorks drawings.
Cleaning Validation Specialist
(PR West - Añasco)
We are looking for a Cleaning Validation Specialist with Medical Device or Pharmaceutical manufacturing experience to develop and execute the cleaning validation process.
Essential Functions:
- Perform assessments on Cleaning Test Methods, including drive, implement and/or support actions towards findings resolution and implementation.
- Development and execution of Cleaning Validation Protocols, including data analysis.
- Lead and/or participate in different Cleaning Validation activities.
- Support Cleaning Validation activities and Compliance such as preparing or reviewing validation documentation.
Requirements:
- Knowledge in Cleaning Methods best practices based on pharmaceutical FDA regulation.
- Experience in Test Methods analysis and execution, including ‘hands-on’ experience performing laboratory methods and its documentation process.
- Knowledge in USP Guidelines and ICH Guidelines for Stability Experience in Cleaning Validation activities, including protocols development and execution (URS, DS, Risk Assessments, IQ, OQ, PQ).
- Experience performing Recovery Studies and total organic carbon (TOC) analysis. 5+ years of experience in Cleaning Validation.
- Excellent technical writing skills (both English and Spanish)
- BS in Sciences or Engineering required.
Validation Engineer / Specialist
(PR South - Ponce / PR West - Añasco)
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.
CSV Engineer
(PR West - Añasco)
The CSV Engineer must have experience within process validation and equipment qualification in Pharmaceutical and Medical Devices environments.
Minimum Requirements:
- Bachelor's Degree in an Engineering Field.
- 3-5 years of knowledge and experience in cGMP in a Pharmaceutical or Medical Devices manufacturing environment.
- 3-5 years of computer system validation (IQ, OQ, PQ protocols generation and execution, deviations and reports generation).
- Knowledge in Computer System Validation (CSV) based in System Development Life Cycle (SDLC) and GAMP.
- Project management skills required.
- Strong knowledge and practical experience in system automation and controls.
- Fully bilingual (English and Spanish).
Manufacturing Engineer
(PR South - Villalba)
The Manufacturing Engineer will support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment. Responsible to generate and execute validation protocols for new or replaced equipment, or process changes. Perform initial set-up, conduct and/or support troubleshooting, including continuous improvement, of production equipment and processes. Support investigations process (NCRs, Complaints) and teams with Manufacturing and QA personnel for review and disposition of investigations on time.
Minimum Requirements:
- Bachelor's degree in an Engineering Field.
- 3+ years of knowledge and experience in cGMP in a Medical Devices manufacturing environment.
- 3+ years of equipment qualification and process validation knowledge (IQ, OQ, PQ protocols generation and execution, deviations and reports generation).
- 3+ years of statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e, Minitab).
- Knowledge and skills (1-3 years) in diverse areas such as: Investigations (NCRs, Complaints, CAPA), Lean Manufacturing and Six Sigma Tools.
- Knowledge with pFMEA (analysis and development).
- Highly Motivated, Self Starter and Multi Task Oriented.
- Computer literate (Word, Excel, Power Point, Minitab).
- Excellent communicator (spoken, written) in both, English and Spanish.
Quality Engineer/ Specialist
(PR East - Juncos / PR South - Villalba)
The QA Engineer must have experience within the Pharmaceutical and Medical Devices manufacturing environments. Minimum Requirements:
- Bachelor's degree in an Engineering Field or Science Field.
- 1-5 years of knowledge and experience in cGMP in a Pharmaceutical or Medical Devices manufacturing environment.
- 1-5 years of qualification / validation protocols (IQ, OQ, PQ) development, execution and auditing for NPI projects.
- Proven Knowledge in pFMEA design and analysis, CAPA investigations and analysis.
- Knowledge on statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e, Minitab).
- Project management skills required.
- Fully bilingual (English and Spanish).
Supplier Quality Engineer (SQE)
(PR East - Juncos)
We are looking for a Supplier Quality Engineer (SQE) with Medical Devices manufacturing experience preferred (3+ years). Must possess experience in CAPA, Quality Tools and Suppliers Selections programs. Understanding of SPC and GD&T.
Essential Functions:
- Review and approve qualification plans and reports to ensure components, materials and supplier meet specified requirements.
- Applies problem-solving skills to the corrective action process and eliminate problem root cause through long-term preventive action.
- Facilitates and reports the progress of supplier corrective actions as assigned by relevant SCAR system.
- Reviews potential or material quality issues to drive, implements and support corrective/preventive actions with suppliers (SCRs).
- Drives and/or supports supplier development programs in an effort to improve receiving inspection process and corrective and preventive components related rejection in manufacturing and field.
- Supports incoming inspection activities.
- Resolve material quality issues, specifications, and inspection procedures questions at the incoming inspection area.
- Evaluates, selects, validates, and qualifies equipment /tools / technologies for accurate inspection, including fulfilling financial requirements for capital equipment acquisitions.
- Perform R&R and capabilities studies as required.
- Perform, review and/or approve vendor related investigations for NCRs & SCARS to ensure effective problem resolution associated to raw material/components.
- Evaluate and approve incoming inspection plans.
- Lead and/or participate in supplier development projects and continuous improvement activities focusing on supplier quality.
- Act as liaison between vendors and EQVAL customers (Engineering and the Quality Assurance Department) to resolve quality problems with components.
- Work with internal customers in support of the inspection level program and optimize inspection requirements.
Engineering Technician
(PR East - Juncos )
The Engineering Technician must have exposure at Medical Device or Pharmaceutical Industry executing duties in a manufacturing environment including following:
Minimum Requirements:
- Education Required: Bachelor’s, Associate or further in technical area (Educational: Electronics, Mechanical, Engineering, Technology, or related field)
- Basic knowledge of troubleshooting.
- Basic knowledge with Vision System and servo motors.
- Basic knowledge with pneumatic, electrical and pneumatic duties.
- Basic knowledge of Laser Welding and Leak Tester machines.
- PLC programing Vision System understanding and programing.
- Automation equipment integrations and modifications.
- Performs a variety of duties in the electronic, mechanical, electromechanical, and/or optical areas.
- Constructs, troubleshoots, tests, and diagnoses components, devices, or systems.
- Provides engineering support to the manufacturing line.
- Responsible, organization, communication and interpersonal skills, team-work.
- Basic Knowledge of CAD software such as Solid Works or Auto CAD.
- Provides engineering support to the manufacturing line.
- Conducts experiments / tests for engineer.
- Collects and analyzes numeric data (analytical thinking)
- Assists in the adequate disposition to non-conforming product/material (P.R.B.)
- Computer Knowledge
- Bilingual: Spanish and English
BE PART OF THE EQVAL WORK TEAM!
How to apply? Send your resume to info@eqvalconsultinggroup.com
