LL03-112425 PD Technician for Medical Devices
Medical laboratory scientist job in Guaynabo, PR
Job Description
Validation & Engineering Group, Inc.
(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Process Development Technician
Purpose Statement: Supports development of capable processes and ensures efficient and effective transfer of products into production. Contributes with Process Development engineers, scientists, and/or teams in the development and analysis of processes and equipment. This position requires high independence and knowledge on automated manufacturing equipment.
Key Responsibilities:
Executes functional deliverables associated with Process Development and Technology Development projects.
Assesses process capabilities, innovates, and implements process improvements on complex processes.
Work with engineers and internal/external vendors to maintain/fix/calibrate/qualify manufacturing equipment.
Support testing or manufacture of prototypes/materials with minimal engineering guidance.
Organize and document testing data and prepare reports/documentation to communicate results.
Applies technical knowledge to support, design, and the development of processes, procedures, tooling and automation.
Typically makes important technical contributions as part of an extended team.
Work cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain and Marketing to ensure project success.
Identifies problems and proposes solutions to technical challenges. Independently solves basic issues within functional area.
Supports, researches, and evaluates new technologies within functional area. Remains knowledgeable of available technologies within functional area. May identify new applications for established technologies.
Familiarity with a variety of technologies and equipment used in the industry to carry out manufacturing processes, such as Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, general experience with automated equipment (PLC/Servos/Pneumatics/ Sensors), etc.
Ability to collaborate with other engineers, scientists, and production personnel to achieve manufacturing process development objectives and solve problems effectively.
Train others on new product processes and procedures.
Required Qualifications:
Associate's degree or equivalent combination of education/work experience
1-2 years of related experience
Proven record of working closely and successfully with manufacturing and process development engineers
Basic understanding of medical device documentation requirements
Great attitude and strong desire to learn new skills
Preferred Qualifications:
Manufacturing background
Medical Device industry experience
Good technical writing skills
Ability to read electrical prints and schematics
CSV Specialist-Laboratory
Medical laboratory scientist job in Manat, PR
QRC Group, LLC
is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website ************************ to learn more about our services and solutions!
Job Description
The CSV Specialist - Laboratory to lead and execute computer systems validation activities associated with the decommissioning of laboratory equipment, instruments, and systems. This role ensures compliance with regulatory requirements and internal standards during retirement, archival, and documentation of assets and data within a GMP-regulated environment.
Responsibilities
Decommissioning Execution
Generate and manage Change Controls related to laboratory decommissioning.
Prepare and execute CSV Decommissioning Packages for equipment, instruments, and computerized systems.
Coordinate final calibration and cleaning documentation for decommissioned assets.
Manage CMMS retirement/inactivation documentation and update/deactivate assets in Maximo (equipment, instruments, computer systems).
Review and archive preventive maintenance job plans, calibration records, and spare parts inventories.
Collect and archive equipment/instrumentation manuals and technical documentation.
Prepare and submit Finance Decommissioning documentation.
Data Integrity & System Controls
Perform system periodic assessment verification, audit trail reviews, and user access evaluations.
Coordinate backup and archival of electronic data in compliance with data integrity standards.
Review and update or retire SOPs, forms, and validation documents.
Evaluate open records including Data Integrity Assessments, investigations, CAPAs, Infinity records, change controls, and change actions.
Verify and remove hardware components as part of system retirement.
Compliance & Documentation
Coordinate closure of EHS-related change actions.
Update and archive technical drawings associated with decommissioned assets.
Compile and deliver turnover packages for final QA review.
Ensure proper closure of change controls and documentation handoff.
Qualifications
Bachelor's degree in Science or related field.
Minimum 3 years of experience in CSV, QA, or laboratory systems within a regulated environment.
Strong understanding of GMP, data integrity principles, and system lifecycle management.
Experience with CMMS systems (e.g., Maximo), calibration documentation, and electronic data archival.
Fluent in English and Spanish (spoken and written).
Additional Information
All your information will be kept confidential according to EEO guidelines.
V&EG's Bio Pharma Fair- Virtual Job Fair
Medical laboratory scientist job in San Juan, PR
Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, manufacturing operations among other services.
Job Description
V&EG's Bio Pharma Fair is the exclusive online job fair organized by Validation & Engineering Group, entirely dedicated to professionals in the
medical, biomedical, healthcare, pharmaceutical and biotechnological sectors with at least one of these experiences:
* Commissioning, qualification, validation
* CSV life cycle experience
* Automation
* QA/QC
* Project Management
* Facilities/Maintenance Engineering
* EHS
Qualifications
V&EG's Bio Pharma Fair is addressed to
young professionals
with a biomedical, biotechnological, pharmaceutical, medical and healthcare, medical and biomedical engineering or Science background coming from
Puerto Rico and United States
.
Minimum of three (3) years of experience in the mentioned sectors.
Additional Information
Positions available for Puerto Rico and The United States.
Only candidates that meet the minimum requirements will be considered.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.
Medical Technologist I
Medical laboratory scientist job in Carolina, PR
Job Description
Who are we?
For more than 26 years, CorePlus has provided Puerto Rico with anatomical pathology laboratory services and clinical analysis with innovation and precision. Our commitment is,
to be a leader in the transformation of pathology to the digital world
.
In 2020 we deployed our digital pathology platform, being the first organization in Puerto Rico to make the transformation. Known worldwide for operationalizing the use of Artificial Intelligence (AI) in the diagnosis of prostate and breast cancer, CorePlus stands out for being avant-garde.
If innovation and compassion appeal to you, we invite you to join our mission and become part of our family; we offer excellent benefits including health plan, dental, vision, 401k, paid vacation, and life insurance.
The Position
Under direct supervision, the Medical Technologist 1 (MT1) is responsible for the receiving, processing and analyzing of samples. Provides medical information to organizations and establishments to be used to diagnose, treat, and prevent diseases in a clinical and occupational medicine setting. To accurately perform and report all in-house laboratory testing procedures and obtain the necessary specimens for reference laboratory testing, as required. Enhances the efficiency and accuracy of lab testing by maintaining adequate laboratory supplies, by keeping equipment in operational condition and by maintaining a clean and orderly laboratory work area. Assists in the preparation of monthly statistical reports by keeping accurate records on all laboratory procedures performed.
Responsibilities
Conducts analysis on various body fluids such as urine, whole blood and gynecological samples for clinical and molecular studies.
Prepares blood and plasma for a variety of laboratory reference tests.
Analyzes and identifies blood and urine cells using a microscope techniques and procedures.
Keep laboratory equipment's clean, functional, and calibrated. Completing preventive maintenance requirements; following manufacturer's instructions; troubleshooting malfunctions; calling for repairs; maintaining equipment inventories; evaluating new equipment and techniques.
Maintains safe and clean working environment by complying with procedures, rules, and regulations.
Organizes laboratory supplies and maintains laboratory inventory records by checking stock to determine inventory level; anticipating needed supplies; expediting orders for supplies; verifying receipt of supplies.
Properly and safely disposes of hazardous and infectious waste and materials.
Respects patient confidentiality laws.
Compiles thorough and professional laboratory reports.
Updates and maintains knowledge base by attending workshops, reading, and participating in professional organizations.
Ensures accurate laboratory testing by performing phlebotomy on patients when necessary.
Prepares reports of technological findings by collecting, analyzing, and summarizing information.
Maintains inter- and intradepartmental workflow by fostering a spirit of cooperation.
Protects patients and employees by adhering to infection-control and hazardous waste policies and protocols, following identification procedures.
Contributes to team effort by accomplishing related results as needed.
Maintains quality assurance of the Laboratory by performing proficiency testing.
Performs QC reporting.
Any other related responsibility not previously described.
Requirements and Skills
Bachelor's degree in biology
Postgraduate in Medical Technology
Licensed Medical Technologist
ASCP Certified
0-7 years' experience as a Certified Medical Technologist
Standardized knowledge in the fields of clinical chemistry, hematology, Phlebotomy, immunology, Microbiology, and urinalysis
Knowledge in complex techniques such as PCR and Andrology testing
Working Conditions/ Physical Activity:
While performing the duties of this job, the employee is regularly required to talk and listen.
The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.
The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
CorePlus
is an equal employment/affirmative action opportunity employer. It does not discriminate against any qualified person on the basis of sex, race, color, national origin, religion, sexual orientation, age, marital status, mental, physical or sensory disability, or any other classification protected by applicable local, state, federal, and/or international law.
Laboratory Technician I MEC - (3rd Shift)
Medical laboratory scientist job in Barceloneta, PR
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* .
Job Description
Purpose
Describe the primary goals, objectives or functions or outputs of this position.
The QC Tech I performs laboratory testing within a fast paced GMP environment in support of one or more of the following areas; raw materials, environmental monitoring, in-process product, final Bulk product, stability, and/or validation. Analyzes test data and evaluates results. Writes procedures with guidance. Works under the guidance of a supervisor but is able to manage time efficiently in achieving timely completion of assigned duties.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
+ Perform the environmental monitoring sampling conducted during the Small Volume Parenteral commercial filling and media fill.
+ Perform utilities and facilities environmental monitoring such as non-viable particulate, viable air and surface sampling.
+ Perform microbiological testing and documentation for manufacturing process samples, raw materials, in process samples and final product following procedures, methods and specifications within the required time.
+ Perform general cleaning/maintenance of laboratory equipment such as incubators, refrigerators amongst others and required per procedures.
+ Maintain the materials, reagents, and media inventory required in the laboratory.
+ Ensure samples are collected and/or tested according to schedule and following applicable procedures and analysis are accurately documented.
+ Provide support during validations, special sampling, and planned or unplanned reinstatements.
+ Complete training and certifications on time as established in the training curriculum.
+ Perform preventive maintenance to the laboratory equipment, as applicable.
+ Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.
Qualifications
Qualifications
List required and preferred qualifications (up to 10). Include education, skills and experience.
+ Associate degree in Science required. Major in Biology, Chemistry, Microbiology or Medical Technology is strongly preferred.
+ No previous experience required. Basic knowledge of laboratory techniques preferred.
+ Computer knowledge such as Microsoft Word, Power Point, Excel, etc.
+ Basic verbal and written communication skills in English and Spanish.
Key Stakeholders
Development, Manufacturing, Quality and Regulatory
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit *************************************************************************
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
*************************************************************
CSV Specialist - Laboratory
Medical laboratory scientist job in Manat, PR
QRC Group, LLC
is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website ************************ to learn more about our services and solutions!
Job Description
The CSV Specialist - Laboratory to lead and execute computer systems validation activities associated with the decommissioning of laboratory equipment, instruments, and systems. This role ensures compliance with regulatory requirements and internal standards during retirement, archival, and documentation of assets and data within a GMP-regulated environment.
Responsibilities
Decommissioning Execution
Generate and manage Change Controls related to laboratory decommissioning.
Prepare and execute CSV Decommissioning Packages for equipment, instruments, and computerized systems.
Coordinate final calibration and cleaning documentation for decommissioned assets.
Manage CMMS retirement/inactivation documentation and update/deactivate assets in Maximo (equipment, instruments, computer systems).
Review and archive preventive maintenance job plans, calibration records, and spare parts inventories.
Collect and archive equipment/instrumentation manuals and technical documentation.
Prepare and submit Finance Decommissioning documentation.
Data Integrity & System Controls
Perform system periodic assessment verification, audit trail reviews, and user access evaluations.
Coordinate backup and archival of electronic data in compliance with data integrity standards.
Review and update or retire SOPs, forms, and validation documents.
Evaluate open records including Data Integrity Assessments, investigations, CAPAs, Infinity records, change controls, and change actions.
Verify and remove hardware components as part of system retirement.
Compliance & Documentation
Coordinate closure of EHS-related change actions.
Update and archive technical drawings associated with decommissioned assets.
Compile and deliver turnover packages for final QA review.
Ensure proper closure of change controls and documentation handoff.
Qualifications
Bachelor's degree in Science or related field.
Minimum 3 years of experience in CSV, QA, or laboratory systems within a regulated environment.
Strong understanding of GMP, data integrity principles, and system lifecycle management.
Experience with CMMS systems (e.g., Maximo), calibration documentation, and electronic data archival.
Fluent in English and Spanish (spoken and written).
Additional Information
All your information will be kept confidential according to EEO guidelines.
Laboratory Technician I MEC - (3rd Shift)
Medical laboratory scientist job in Barceloneta, PR
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Purpose
Describe the primary goals, objectives or functions or outputs of this position.
The QC Tech I performs laboratory testing within a fast paced GMP environment in support of one or more of the following areas; raw materials, environmental monitoring, in-process product, final Bulk product, stability, and/or validation. Analyzes test data and evaluates results. Writes procedures with guidance. Works under the guidance of a supervisor but is able to manage time efficiently in achieving timely completion of assigned duties.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
* Perform the environmental monitoring sampling conducted during the Small Volume Parenteral commercial filling and media fill.
* Perform utilities and facilities environmental monitoring such as non-viable particulate, viable air and surface sampling.
* Perform microbiological testing and documentation for manufacturing process samples, raw materials, in process samples and final product following procedures, methods and specifications within the required time.
* Perform general cleaning/maintenance of laboratory equipment such as incubators, refrigerators amongst others and required per procedures.
* Maintain the materials, reagents, and media inventory required in the laboratory.
* Ensure samples are collected and/or tested according to schedule and following applicable procedures and analysis are accurately documented.
* Provide support during validations, special sampling, and planned or unplanned reinstatements.
* Complete training and certifications on time as established in the training curriculum.
* Perform preventive maintenance to the laboratory equipment, as applicable.
* Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.
Qualifications
Qualifications
List required and preferred qualifications (up to 10). Include education, skills and experience.
* Associate degree in Science required. Major in Biology, Chemistry, Microbiology or Medical Technology is strongly preferred.
* No previous experience required. Basic knowledge of laboratory techniques preferred.
* Computer knowledge such as Microsoft Word, Power Point, Excel, etc.
* Basic verbal and written communication skills in English and Spanish.
Key Stakeholders
Development, Manufacturing, Quality and Regulatory
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
* The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
* We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
* This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit *************************************************************************
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
*************************************************************