At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Job Responsibilities:
* Administer and lead a team to support manufacturing operations following manufacturing Standards for Operational Excellence.
* Lead and organize the work priorities and objectives, aligned with the business vision and mission.
* Act as a leader, integrator, and have accountability for the objectives, ensuring safety, quality, and compliance performance by the application of operational excellence principles.
* Supervise staff and ensure there is an adequate number of qualified personnel to support the operation.
* Manage the budget and provide input to the Strategic and Business Planning processes.
* Ability to lead and integrate cross-functional teams in both production and material management environments.
* Experience managing warehouse operations, including inventory control and dispensing processes.
* Ability to lead and integrate cross-functional teams in both production and material management environments.
* Experience managing warehouse operations, including inventory control and dispensing processes.
Education Requirements:
* Bachelor's or master's degree in engineering, science or business administration
Experience Requirements:
* At least (5) years of experience in related area.
* Experience leading group of work.
* Bilingual (English and Spanish)
* Experience in project management and change management
Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$108,000 - $173,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$108k-173.8k yearly Auto-Apply
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Pharmacy Help Desk Call Center Representative
Pharmpix Corporation
Guaynabo, PR
The Pharmacy Help Desk Call Center Representative reports to the Pharmacy Help Desk Call Center Supervisor and is responsible to provide a customer service by telephone of incoming and outbound calls to providers, beneficiaries and pharmacies.
ESSENTIALS ROLES AND RESPONSIBILITIES
Answer incoming pharmacy calls regarding issues related to a claim transaction, reimbursement, payment, and other required information in accordance with PharmPix Pharmacy Help Desk Call Center performance metrics.
Answer incoming providers' and beneficiaries' calls following Call Center scripts, in a timely matter and in accordance with PharmPix call center performance metrics.
Answer incoming calls and perform outbound calls according to HIPAA and Pharmacy Laws Standards.
Identify pharmacies, providers and beneficiaries needs, clarify information, research every issue and providing solutions.
Document all inquiries in the Customer Service Management Applications such as, Service Desk, OneArk and email.
Route the case to the corresponding internal department or the appropriate Health Insurance Carrier.
Guide pharmacies, providers and beneficiaries regarding the process of claim transmission, reimbursement and payment.
Constantly monitors the BACMAN Alert Application to ensure proper management of rejections at point of sale.
Evaluate on an individual basis to determine if the patient meets the criteria for a coverage determination for alerts such as DURs (Drug Utilization Reviews), HMO (Health Maintenance Organization) among other rejections evaluations required by business.
Identify system issues and route to the corresponding internal department.
Make outbound calls to pharmacies, providers and beneficiaries if necessary.
Support all Quality Management Program initiatives.
Perform Special projects and/or other duties assigned by the Operations Manager and or Pharmacy Help Desk Call Center Supervisor.
TRAINING & EDUCATION
Pharmacy Technician, Technical or Associate Degree
LICENSURE / CERTIFICATION
Puerto Rico Board of Pharmacy Technician Registry Certificate (CPhT), or prospect.
PROFESSIONAL EXPERIENCE
1 - 2-year customer service or call center experience and healthcare environment (Preferable).
PROFESSIONAL COMPETENCIES
Knowledge:
Fully Bilingual (Spanish / English written and verbal).
PC skills (Microsoft System)/System oriented.
Skills:
Strong customer service skills.
Excellent phone, written, active listening and follow-through skills.
Skill in analyzing situations accurately and taking effective action.
Attention to details.
Time Management Skills: Establishing priorities and accomplishing tasks in a timely manner.
Ability to work with others to reach a solution.
Be able to toggle between several software programs.
Demonstrated effective organizational skills.
Abilities:
Able to effectively interact with internal departments, PharmPix clients, members and other healthcare professionals.
Ability to work with others to reach a solution.
Be able to toggle between several software programs.
Ability to work in a fast-paced environment and multitask.
PHYSICAL AND MENTAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear, sitting, standing and walking.
The position requires that weight be lifted and force be exerted up to 25 pounds.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
ENVIRONMENTAL AND WORKING CONDITIONS
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Require evening or weekend work.
PharmPix is an Equal Employment Opportunity Employer Minorities / Females / Disable / Veterans
$16k-21k yearly est. Auto-Apply
LL02-251008 TOP Documentation Specialist
Validation & Engineering Group
Juncos, 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:
TOP Documentation Specialist
The TOP Documentation Specialist is responsible for the collection, review, organization, and delivery of Turnover Packages (TOPs) for all packaging line equipment, systems, and supporting utilities within a GMP-regulated biotechnology site.
This role ensures that all engineering, commissioning, qualification, and vendor documents are accurate, complete, and compliant with site standards, FDA/EMA regulations, and project milestones for system handover to Operations and Quality.
Key Responsibilities:Turnover Package Management
Develop and maintain the TOP index, trackers, and matrix for all packaging lines and supporting systems (e.g., filling, labeling, cartoning, serialization, aggregation, utilities).
Coordinate with Engineering, Commissioning (Cx), Validation (CQV), Quality, and Construction teams to ensure all required records are submitted on time.
Collect and compile key documents, including:
URS, BOD, design drawings, vendor manuals, material certifications, weld maps, FAT/SAT, IQ/OQ/PQ, calibration reports, EHS certifications, and training records.
Review all documents for accuracy, revision control, signatures, and GMP compliance before final handover.
Compliance & Documentation Control
Ensure all TOP documentation complies with GMP, FDA 21 CFR Part 11, GAMP 5, and data integrity requirements.
Support audit readiness by maintaining organized, retrievable, and secure records (electronic and hard copy).
Work with the Quality Unit to ensure final TOP approval and proper archiving into the site's document control system (e.g., Veeva, Documentum, or MasterControl).
Project Support & Coordination
Act as the central point of contact for document status, gaps, and deadlines for turnover deliverables.
Support engineering change controls, redlining of P&IDs/drawings, and transmittal logs as needed.
Prepare weekly progress reports on TOP completion percentages and outstanding items for project leadership.
Assist in the development of standard templates, workflows, and lessons learned to improve future turnover execution.
Qualifications:
Required:
Associate or Bachelor's degree in Engineering, Technical Sciences, or Document Control/Information Management (or equivalent experience).
3+ years of experience in TOP/document control in a GMP pharmaceutical, biotech, or regulated construction project environment.
Strong understanding of GMP documentation, Cx/Qx deliverables, validation protocols, and FDA/EMA compliance.
Proficiency with MS Excel/Word, PDF markup, and document control software (Veeva, MasterControl, Documentum, SharePoint).
Strong organizational skills with attention to detail, version control, and deadlines.
Preferred:
Experience supporting packaging line installation and turnover in biotech or pharmaceutical facilities.
Familiarity with Kneat or other e-CQV platforms for commissioning/qualification documentation.
Knowledge of LEED commissioning and sustainability-related documentation for energy and atmosphere credits.
Excellent communication and stakeholder coordination skills.
Core Competencies:
Attention to Detail & Data Integrity - Ensures every record is audit-ready.
Organizational Excellence - Manages large volumes of documents across multiple systems.
Collaboration & Communication - Serves as a bridge between engineering, quality, and construction teams.
GMP Compliance Focus - Understands the criticality of accurate turnover for regulatory approval and operational readiness.
$25k-46k yearly est.
Electronic Engineering Technician
Watsco, Inc. 4.4
Guaynabo, PR
Job Function: Work in a factory environment and will be responsible for installing, replacing, and repairing circuit boards. Primary responsibilities * Setting up and circuits boards systems by following schematics and diagrams * Troubleshooting problems with circuits boards and making necessary repairs.
* Conducting service checks and performing routine maintenance to keep circuits boards functioning properly.
* Communicating with operators, technicians, engineers, and customers to understand problems and provide progress updates.
* Giving demonstrations on the safe use, operation, and maintenance of equipment.
* Ordering or producing parts needed to make repairs and complete maintenance.
* Maintaining logs that provide dates and details of repairs and maintenance performed.
* Adhering to health and safety rules and regulations
Skills and Qualifications:
* Demonstrable skills in circuit board repair and soldering
* Work without supervision
* Basic understanding of circuits and components (resistor, transformers, capacitors etc.)
* Preferable with experience in Pharmaceutical Industry
* Excellent attention to detail, good time management skills
* Problem-solving skills to diagnose issues and devise solutions.
* Observational skills to notice potential problems during service checks.
* Demonstrated proficiency at interpreting diagrams and schematics.
* Written communication skills to keep accurate, easy-to-understand reports.
* Interpersonal and oral communication skills to interact, collaborate and provide instruction.
* Working knowledge of health and safety standards
* Knowledge in technical reports and documentation
* Computer literate
* Good writing and communication skills (English and Spanish)
Physical Demands:
* While performing the duties of this job, the employee may be regularly required to sit, stand, bend, reach and move about the facility.
* Must be able to lift and carry up to 50 pounds and comply with OSHA standards.
Education Experience Requirements
* BA in Electronic Engineer
* Prior experience two years with electronic repair
Education Experience Requirements
* BA in Electronic Engineer
* Prior experience two years with electronic repair
$56k-65k yearly est.
Manufacturing Operator
Eli Lilly and Company 4.6
Carolina, PR
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Manufacturing Operator
Company:** Lilly del Caribe, Inc.
Las tareas y deberes generales de un operador incluyen:
Seguir las instrucciones y procedimientos de manufactura, según están establecidos.
Preparar e inspeccionar equipos y documentación durante los procesos de Manufactura.
Hacer cambio de turno con los operadores del turno anterior.
Reportar inmediatamente cualquier discrepancia en el proceso, procedimiento o especificaciones de producto o proceso.
Disponer correctamente todo desperdicio generado en el área de trabajo.
Cumplir con el plan de adiestramientos aplicable a su área de trabajo.
Participar en el proceso de adiestrar a otras personas.
Ser responsable de su seguridad y la de sus compañeros cumpliendo con las expectativas de Salud y Seguridad Ocupacional y Ambiental.
Participar en un equipo de trabajo, según sea requerido.
Tener conocimiento en el uso y manejo de sistemas como Quality Docs, SAP y Apogee.
Realizar y/o aprobar limpiezas.
Requisitos Básicos:
Grado Asociado en ciencias, instrumentación o mecánica aplicada.
Conocimiento y experiencia ejecutando operaciones de manufactura, incluyendo ajuste de parámetros críticos, manejo de
tooling
y troubleshooting.
Conocimiento de las buenas prácticas de manufactura (cGMP, por sus siglas en inglés).
Otros Requisitos:
Bilingüe (español e inglés) y habilidad de leer e interpretar, y de expresión oral, escrita y de redacción.
Disponibilidad para trabajar turnos rotativos incluyendo fines de semana y feriados.
Uso de equipo de protección personal, incluyendo respiradores de aire.
Conocimientos en sistemas computadorizados.
Disponibilidad para trabajar como recurso en otras áreas, según las estrategias del negocio.
Licencia para manejar montacargas
Aviso importante: Con el fin de mantener la excelente reputación de nuestra empresa, la calidad de nuestros productos y la seguridad de nuestro entorno de trabajo, la empresa tomará todas las medidas razonables para garantizar que el abuso de drogas por parte de los empleados u otras personas no ponga en peligro la seguridad de nuestras operaciones o la calidad de nuestros productos ni afecte negativamente de ninguna manera a la empresa o a sus empleados. La compañía reconoce que el consumo de drogas, tanto dentro como fuera del trabajo, puede ser perjudicial para la compañía y sus esfuerzos por proporcionar un lugar de trabajo libre de drogas. Incluso si se prescribe bajo una ley estatal de marihuana medicinal, la marihuana sigue siendo ilegal bajo la ley federal. La marihuana es considerada no autorizada por Lilly.Lilly es un empleador de EEO/Acción Afirmativa y no discrimina por motivos de edad, raza, color, religión, género, orientación sexual, identidad de género, expresión de género, origen nacional, estado de veterano protegido, discapacidad o cualquier otro estado legalmente protegido.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$12.98 - $32.00
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$18k-21k yearly est. Auto-Apply
Internal Audit Associate
Clear Blue Insurance Services Puerto Rico LLC
Guaynabo, PR
The Internal Audit Associate will support the Internal Audit Department in executing audits, documenting processes, and assessing internal controls across all business units. This role requires strong analytical skills, attention to detail, and the ability to collaborate effectively with the audited areas. The Internal Audit Associate will help ensure compliance with regulatory requirements (including SOX, Texas DOI, and other applicable frameworks), promote operational efficiency, and provide valuable insights for process improvements.
KEY RESPONSIBILITIES:
Audit Execution
Assist in conducting internal audits across functional areas such as Claims, Underwriting, HR, Finance, Legal, and IT.
Perform testing of controls to evaluate compliance with SOX and company policies.
Document audit findings and prepare clear, concise working papers.
Support the development of audit reports and follow-up on remediation actions.
Process Documentation
Work alongside process owners to document workflows, SOPs, and process narratives in a standardized format.
Assist in creating flowcharts, risk-control matrices, and supporting documentation.
SKILLS & QUALIFICATIONS
Strong analytical, problem-solving, and critical thinking skills.
Excellent verbal and written communication abilities, including preparing clear documentation and reports.
High attention to detail, with ability to work independently and manage multiple priorities.
Proficiency with Microsoft Office (Excel, Word, PowerPoint, Visio) and SharePoint.
Knowledge of insurance operations (Claims, Underwriting, MGA/TPA oversight) is desirable but not required.
EDUCATION AND EXPERIENCE:
Bachelor's degree in Accounting, Finance, Business Administration, or related field.
1-3 years of experience in internal audit, external audit, or related fields (Big Four, consulting, or insurance industry experience is a plus).
Familiarity with SOX compliance, internal controls, and regulatory frameworks.
Experience documenting processes and/or working with flowcharts and narratives
$49k-56k yearly est. Auto-Apply
Quality Application Specialist
Mg Staffing Group
Juncos, PR
Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations. Coordinates activities with clients, programmers\/developers and operating personnel, domestic and, as appropriate, global. Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications. Reports on the status of validation activities to fulfill regulatory requirements. Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques. Performs system administration and configuration of quality information technology systems. Perform other duties assigned.
Requirements Minimum 5 years of experience in the regulated industry. Experience in with Process Validation and Computer System Validation. Experience in Medical Devices Regulatory and Technical background. Bachelor Degree in Science or Engineering completed. Bilingual. Willing to work 100% On\-site in Juncos, PR.
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$60k-78k yearly est.
Data Entry
Mettel 4.3
Guaynabo, PR
Job Description
MetTel is a global communications solutions provider with the most complete suite of fully managed services that focus on secure connectivity, and network and mobility services. We simplify communications and networking for business and government agencies. Our customers include many of the Fortune 500, and Gartner recognizes us as an industry leader. We have the broadest portfolio of technology and integrated partnerships, as well as our private network, which we use to create tailored solutions design, deployment, and ongoing management, driving cost savings, efficiency, innovation, and the ability to focus on core objectives.
We believe that each team member is a key to the success and sustainability of the group. In order to achieve this, we offer an environment where all professionals can grow and develop their skills and competencies, collaborate with diverse professionals, share knowledge and enjoy a rewarding career.
We are looking for a Data Entry Operator to join our team!
Role & Responsibilities:
· Gather invoices from vendors by calling and requesting invoices
· Insert billing data into expense management system
· Detailed data keyed into the expense management system
· Complete required account level changes within expense management system
· Download invoices from vendor portals and load into expense management system
· Keep information confidential
Qualifications:
· 2+ years in data entry
· Utilities or Telecommunications experience a plus
· Experience with MS Office programs (Excel, Word, and MS Teams)
· Experience with web portals
· Ability to stay focused on assigned tasks
· Great attention to detail
· Positive can-do attitude
· High School Diploma or equivalent
Job Type: Full-time
*The pay reflected is a good faith estimate of pay for the primary location of the position. Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The U.S. pay rate for this position is $11.50 per hour. Pay varies by work location and may also depend on job -related knowledge, skills, experience and abilities of the successful candidate. Your recruiter can share more about the specific salary range for the job location during the hiring process.
MetTel is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws.
To learn more about our company visit us at **************
$11.5 hourly
Test Center Administrator (PT)
Prometric 4.3
Guaynabo, PR
JOB TITLE: Test Center Administrator REPORTS TO: Test Center Manager DEPARTMENT: Test Center TEST CENTER ADDRESS: Metro Office Park, Street 1, Building 11, Office 114 Please complete this brief questionnaire What To Expect On First Day(VIDEO)
JOB OVERVIEW:
The Test Center Administrator (TCA) serves as the face of Prometric in test centers around the world. These emerging professionals are part of a growing specialization within the company and thrive in fast-paced environments that support people who are taking life-changing exams. The position requires TCAs to verify candidate identification, monitor exams and maintain strict policies and guidelines to uphold the highest standards for exam integrity in the world.
Prometric employs more than 600 TCAs worldwide who are highly respected for their ability to lead and control the computer-based test center environment.
PERKS for employees hired for 20+ hours: (DO NOT EDIT)
12 Paid Holidays Off annually based on work schedule and start date
No selling or quotas
Office setting environment
No inventory, stocking, floor moves or overnight shifts!
Paid training
Sick time prorated based on start date
401K
Employee Assistance Program
Vision
FSA
Include these PERKS for employees hired for Full Time: (DO NOT EDIT)
Legal
Vacation
AVAILABLE SCHEDULE:
Part Time - Hours Will Vary
Schedule: Site may be open Monday through Saturday 7am to 6pm. Saturday availability required. Occasional evening hours required. Possible, Sunday hours.
Our ideal candidate demonstrates teamwork, with the availability to work a variety of shifts any day - Monday through Saturday - between the hours of 7am and 10:00 pm. Candidate must be open to flexible scheduling.
This is strictly a part-time position and will remain as such, 20 hours per week, with an expectation to work more hours if needed.
Schedules are available 2 weeks in advance.
RESPONSIBILITIES:
Maintain and apply expert knowledge of test center policies, practices and procedures
Greet examinees and verify identification
Perform required security checks including the use of wands
Continuously monitor candidates as they complete exams
Report and/or resolve candidate issues with urgency
Maintain secure environment and materials in the test center at all times
Ensure every candidate receives a fair and comfortable testing experience
Report any occurrences outside company guidelines
Ability to be flexible with scheduling based on Prometric days of operations
Represent Prometric's vision, mission and values
Safeguard the test center from misconduct
If applicable, digitally scan and record candidate fingerprint identification
QUALIFICATIONS:
EDUCATION:
High school diploma or equivalent required
College experience a plus
EXPERIENCE:
Minimum of one year of customer service experience required, in person (call center, retail, restaurant, etc.)
Must be 18 years of age to qualify
SKILLS:
Ability to communicate professionally and effectively with candidates and coworkers
Ability to write detailed and accurate reports and correspondence
Ability to multi-task and handle small tools, pack equipment for shipping or unpack for installation
Familiar with Microsoft Windows-based computer programs and applications (including but not limited to MS Office, Outlook, Explorer-web browsing)
PHYSICAL JOB REQUIREMENTS
Must be able to bend, stoop, and lift up to 40 pounds
Ability to remain in a stationary position for extended periods of time while administering exams
Ability to physically move through test room every 8-10 minutes and escort candidates to and from testing room
Visual requirements include the ability to adjust or focus computer screens and view testing room through camera monitors while proctoring the exam
Ability to maintain computers in the lab and office setting, by physically maneuvering in tight spaces, while maintaining safety protocols
$23k-25k yearly est.
Consultant, Customer Contract Admin
Cardinal Health 4.4
Guaynabo, PR
What Customer Contract Administration contributes to Cardinal Health Sales Administration/Operations is responsible for supporting the sales organization and driving operational excellence in order to achieve the strategic and sales objectives established by the sales organization. This includes sales tools/productivity improvement, customer contract administration, business metrics/analytics, and rewards architecture.
Customer Contract Administration is responsible for conducting research, investigations, and audits related to customer and supplier pricing inquiries, as well as resolving disputes. The role serves as a liaison between internal and external key stakeholders. It also involves managing multiple customer accounts and/or processes within a fast-paced, highly analytical environment. Upon request, the position may assist in preparing responses to RFIs and RFPs. Additionally, it supports the department manager in maintaining contract pricing accuracy and mitigation of errors.
Qualifications
* 4-8 years of experience, preferred
* Bachelor's degree in related field, or equivalent work experience, preferred
* Fully Bilingual English/Spanish is required
What is expected of you and others at this level
* Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
* May contribute to the development of policies and procedures
* Works on complex projects of large scope
* Develops technical solutions to a wide range of difficult problems
* Solutions are innovative and consistent with organization objectives
* Completes work; independently receives general guidance on new projects
* Work reviewed for purpose of meeting objectives
* May act as a mentor to less experienced colleagues
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
$58k-81k yearly est. Auto-Apply
Inventory Specialist
Air Cargo Carriers 4.0
Carolina, PR
Job Description
Inventory Specialist
San Juan, Puerto Rico
Welcome to the world of aviation excellence! As an Inventory Specialist at Air Cargo Carriers (ACC), you'll play a vital role in ensuring our aircraft maintenance operations run smoothly and efficiently. With over 35 years of service across North America and the Caribbean, ACC is a trusted name in Part 135 air cargo operations.
At ACC, we believe our people are our greatest asset. Join a supportive and collaborative team where your contributions directly impact flight safety and operational success.
Position Overview:
Based at the SJU airport, the Inventory Specialist is a key member of the Maintenance and Supply Chain/Logistics team. This role is responsible for the accurate tracking, organization, and distribution of aircraft parts and materials, ensuring timely support for maintenance activities and compliance with aviation standards.
Shift:
Full-time, 40 hours/week
Base schedule of Tuesday to Friday 4am-1pm, and Sundays 3pm-12am, off Saturdays and Mondays.
Also, this team member needs to be flexible and able to work variable shifts, including mornings, evenings, weekends, and holidays, as needed, to cover departmental needs.
Compensation & Benefits:
Competitive hourly pay based on experience
Comprehensive Medical, Dental, Vision, and Life Insurance (Full-Time)
401(k) Retirement Plan
Paid Vacation and Holidays
Key Responsibilities:
Receive, inspect, and document incoming aircraft parts and materials
Maintain accurate inventory records using digital and/or manual systems
Issue parts to maintenance personnel with proper documentation
Monitor stock levels and reorder supplies as needed
Ensure secure and compliant storage of all inventory items
Monitor calibrated tools and maintain related documentation
Prepare shipping documentation for parts transfers or repairs
Conduct regular cycle counts and physical inventory audits
Maintain a clean, organized, and safe stockroom environment
Support compliance with FAA regulations and internal quality standards
Monitor Shelf Due Items
Qualifications:
High school diploma or equivalent (additional training in logistics or aviation is a plus)
Prior experience in inventory control, warehousing, or aviation parts preferred
Familiarity with FAA regulations and aircraft maintenance terminology is not required, but would be a strong advantage
Proficient in basic computer use and inventory software
Strong attention to detail and organizational skills
Ability to lift up to 50 lbs and work in warehouse conditions
Must be authorized to work in the U.S. and pass required background/security checks
Work Environment:
Combination of warehouse and office settings
May require shift work, weekends, and occasional overtime
Additional Information:
ACC is a drug- and alcohol-free workplace. Pre-employment and random substance testing may be required for safety-sensitive positions. We are proud to be an equal opportunity employer.
$27k-31k yearly est.
Validation Specialist
Ultimate Solutions 3.6
Caguas, PR
Education: Engineer, Science Related. IE Prefered
Years of Experience: 3-5
Skills:
Statiscal data Analyst and
Six Sigma Green Belt Certified - Prefered
Knolwlwdge in Validations Strategies Development and Implementations
Product Tranfers
Computer Validation Lifecycle among others
Leader with great interpersonal skills Fully Bilingual
$61k-76k yearly est.
LL02-251022 C&Q Lead - Inspection Lines
Validation & Engineering Group
Gurabo, 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:
The C&Q Lead - Inspection Lines oversees and coordinates all Commissioning and Qualification activities for visual inspection systems used in sterile drug product operations, including both manual and automated inspection technologies. This role ensures equipment, control systems, and supporting utilities are qualified in compliance with regulatory standards (FDA, EMA, Annex 1) and ready for GMP use at site start-up.
Key Responsibilities
Project Leadership & Planning
Lead end-to-end C&Q scope for automated and semi-automated inspection lines, including:
Vision systems for vial, syringe, and cartridge inspection
Conveyance and reject mechanisms
Integration with MES / SCADA / Serialization systems
Container closure integrity test (CCIT) systems
Develop and maintain the Inspection C&Q Master Plan, aligning with the overall site Validation Master Plan.
Coordinate activities across Engineering, QA Validation, Automation, and Manufacturing Operations.
Establish and monitor C&Q milestones for inspection systems to meet project timelines and regulatory readiness.
Commissioning & Qualification Execution
Oversee preparation, review, and approval of URS, FAT/SAT, IOQ protocols, and summary reports.
Ensure equipment and vision systems meet GAMP 5, 21 CFR Part 11, and data integrity standards.
Manage vendor FAT/SAT and site integration testing; ensure punch-list closure.
Supervise execution of C&Q protocols in accordance with ASTM E2500 and ISPE Baseline guides.
Maintain traceability between design requirements and executed testing.
Technical Oversight
Serve as Subject Matter Expert (SME) for vision inspection and serialization systems.
Review and approve:
Vision and camera configuration documentation
Control system design (PLC, HMI, SCADA, MES interfaces)
CCIT and reject logic configuration
Troubleshoot technical issues and support automation integration with packaging and filling operations.
Compliance & Documentation
Ensure C&Q documentation aligns with GMP, GDP, and corporate validation standards.
Support Quality Assurance during audits and regulatory inspections.
Ensure all deviations, CAPAs, and change controls related to C&Q are properly documented and closed.
Maintain digital records in the validation platform (e.g., Kneat or ValGenesis).
Collaboration & Leadership
Work closely with Process Engineering, Packaging, and QA Validation to ensure seamless qualification and handover.
Mentor junior C&Q engineers assigned to inspection or packaging areas.
Participate in daily coordination and readiness meetings to track progress and resolve issues proactively.
QualificationsEducation
Bachelor's degree in Engineering (Mechanical, Electrical, Automation, or related field).
Experience
8+ years of experience in Commissioning & Qualification for pharmaceutical or biotech facilities.
3+ years specific to automated visual inspection or packaging systems.
Experience in aseptic operations and data integrity requirements (GAMP 5, 21 CFR Part 11).
Strong understanding of Annex 1 and ISPE GPG: Visual Inspection of Parenterals.
Technical Competencies
Knowledge of camera systems, vision software, reject mechanisms, serialization, and MES connectivity.
Proficient in using electronic validation tools such as Kneat or ValGenesis.
Skilled in reviewing FAT/SAT documents, IOQ protocols, and risk assessments.
Preferred
Previous experience qualifying inspection lines from Syntegon, Antares, Brevetti, or Seidenader.
Knowledge of CCIT methods (vacuum decay, laser headspace, or HVLD).
Experience in greenfield or expansion projects for aseptic/sterile operations.
$36k-63k yearly est.
Director of Revenue
Accorhotel
Carolina, PR
Fairmont El San Juan Hotel, where lively vibes and peaceful ocean views meet. Located minutes from Old San Juan, on the award-winning Isla Verde Beach in Puerto Rico. The resort features four pools, villa rooms, live entertainment, a Well & Being Spa and Fitness Center, paddleboards, luxury cabanas, signature dining at Caña, El San Juan Beach Club, Meat Market and Chandelier Bar featuring a 7,000 Crystal Chandelier.
What is in it for you
Employee benefit card offering discounted rates at Accor worldwide
Learning programs through our Academies
Opportunity to develop your talent and grow within your property and across the world!
Ability to make a difference through our Corporate Social Responsibility activities, like Planet 21
Job Description
The Director of Revenue Management is responsible for leading the hotel Top Line team in determining strategic vision by establishing goals and implementing tactical efforts. The goal of promoting revenue growth generation among key customer segments and support the hotel's brand positioning and image. Responsible for data analysis, providing gathered intelligence, and recommending revenue and strategies to the revenue team as well as other corporate and ownership entities. Ensure that inventory allocation and pricing parameters are positioned to support the overall revenue goals of the hotel, while assisting all stakeholders in maximizing profit
Qualifications
QUALIFICATION STANDARDS
EDUCATION & SKILLS
Strong knowledge of Opera, Opera Sales & Catering, and IDeaS RMS
Bachelor's degree and/or Hotel Management degree and/or equivalent experience
Strategic thinking with a proven ability to mobilize theory into action
Previous operations experience an asset
Excellent communication and organizational skills
Demonstrate the ability to bring individuals into a team
EXPERIENCE
Minimum of three - five years related experience in similar size hotel/resort
Additional Information
All your information will be kept confidential according to EEO guidelines.
$40k-51k yearly est.
Project Coordinator
Flexible & Integrated Technical Services
Guayama, PR
For Project Coordination services in the Manufacturing and Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree in Engineering or related field and at least five (5) years of previous exposure as Project Forman within the regulated industry.
Bilingual: (Spanish and English)
Shift: Administrative & according to business needs
Experience in:
Project coordination
Field supervision
Regulatory compliance
Technical documentation
Contractor oversight
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Execute small-scale projects and support larger initiatives from concept to close-out.
Assist the Project Manager with estimates, bidding, safety metrics, and cash flow tracking.
Supervise field execution to ensure compliance with company SOPs, values, and global regulations (e.g., cGMP).
Coordinate multi-disciplinary projects aligned with safety, compliance, and operational goals.
Facilitate communication across project teams to ensure smooth execution.
Identify and help resolve technical issues in collaboration with the Project Manager.
Promote and enforce safety and cGMP principles on-site.
Support the development and review of project design documents with external A&E firms.
Help prepare cost estimates and bid packages for construction and equipment.
Monitor contractor work for quality, schedule adherence, and safety compliance.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
$28k-53k yearly est. Auto-Apply
Solar Designer (Auto Cad)
Prosolar
Carolina, PR
ProSolar Systems is looking for an experienced solar professional to manage the life cycle of design and implementation of residential and small commercial projects. Ideal candidates are motivated team players with a strong work ethic and a desire to collaborate effectively in an exciting and dynamic industry. The Design Engineer will work closely with both sales and operations from time of sale through final commissioning of an accurate PV solar project.
Position Overview:
Is responsible for designing code -compliant solar photovoltaic systems for ProSolar Systems. The position requires the designer to have strong experience with concepts and calculations. Successful candidates will have excellent computer skills on multiple platforms and a focus on customer satisfaction and state of the art PV design. The position requires an extreme degree of detail orientation, as well as balancing the high level needs of a solar energy company. The ideal candidate will be able to manage a large volume of projects while demonstrating excellent focus and teamwork.
Primary Job Responsibilities include:
Design residential and small commercial PV systems to meet all customer, company, code and utility requirements and while minimizing cost and maximizing efficiency.
Optimize PV system size to meet customer goals based on electricity use expectations and available solar exposure.
Work with Sales, Project Management, and Installation teams to meet deliver the most accurate and customer -friendly product in a dynamic environment
Work hand -in -hand with technician(s) managing Site Surveys to ensure that the system quoted to the customer can be installed and identify any additional work required to complete the installation (i.e. electrical service upgrades, shade mitigation, roof conditions, etc).
Understand the specific AHJ protocols and mandates, as well as interconnection requirements for each utility.
Work directly with CAD engineers to accurately design one -line diagrams, three -line diagrams, roofing plans, site maps and other documents as required for permits and installer plan sets.
Interact directly with project managers and operational specialists to prioritize work and ensure that design packages are complete, accurate, and processed efficiency to ensure a steady and expedited project pipeline for the company
Coordinate with engineers and other professionals to obtain approvals, stamped drawings, and special forms as required.
Complete the bill of materials listing all special equipment and special items required. Work in sequence with Warehouse Manager to provide accurate forecasts of projects and material considerations.
Update project management software with design and project progress information every step of the life cycle, work with Systems Manager to make improvements to CRM as necessary on a frequent basis.
Perform system energy production estimates and optimize PV system design to balance profitability, customer satisfaction and system performance.
Provided detailed installation notes to provide installers with all information required on each project.
Perform additional duties as assigned and/or directed.
Requirements
Required Skills/Abilities:
-NABCEP certification is a plus.
- Advanced understanding of PV system design and National Electric Code(NEC)
- Experience working with all types of buildings - various roof types: shingle, tile, concrete, metal etc.
- Team player who listens, learns, and actively communicates to the highest degree
- Visual thinkers good at problem solving and implementing ideas while maintaining a positive attitude
- Experience with a customer relationship management system(CRM)
-An extreme attention to detail and unforgiving commitment to quality
Working Conditions:
- This is mainly a computer -based job in an office setting. Visits to field may be necessary or beneficial from time to time. Direct interaction with sales and operation is a daily activity.
-Remote support of various branches is required, so excellent communication through all mediums is vital.
-Must have a valid driver's license and clean driving record to operate company motor vehicles.
Education and Experience:
High school diploma or equivalent
1+ years of solar energy experience in the residential installation space. More experience preferred.
2+ years of experience in Auto Cad
1+ year commercial experience
Benefits
Compensation & Benefits:
Long term stability in a fast -growing industry
Competitive compensation,
Paid Holidays
Generous 401(k) option
Dental insurance
Employer Paid Basic Life and AD&D Insurance
Employer Paid Long Term Disability
Optional Employee Paid - Voluntary Benefits
Health insurance
Life insurance
Vacation and Sick Leave (Accumulative 15 vacations days / 12 sick days)
Vision insurance
Opportunity for career development and advancement with a rapidly growing company
High -energy, fun, and friendly culture
Benefits Package available after 60 days of employment. However some items are subject to meeting eligibility.
Compensation
Compensation may vary based on role, level, experience, length of time in a position, and location. Candidates are not guaranteed to be at the high or low end of the compensation ranges presented. The Company complies with applicable federal, state, and local minimum wage requirements.
Prosolar Systems is proud to be an equal opportunity employer that does not tolerate discrimination or harassment of any kind. Our commitment to Diversity, Inclusion & Belonging drives our ability to build diverse teams and develop inclusive work environments. At Prosolar, we believe that empowering people and valuing their differences will help us create a planet run by the sun for everyone.
We are committed to equal employment opportunity without consideration of race, color, religion, ethnicity, citizenship, political activity or affiliation, marital status, age, national origin, ancestry, disability, veteran status, sexual orientation, gender identity, gender expression, sex or gender, or any other basis protected by law. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. If you have a disability or special need that requires accommodation, please let us know.
$26k-41k yearly est.
Data Integrity Specialist
Pharmeng Technology Americas
Gurabo, PR
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.
Data integrity specialists are responsible for ensuring that data is accurate and consistent across an organization. They commonly work with databases or other large pools of information, looking for errors or inconsistencies that may have been introduced during the collection, storage, or transmission process.
Responsibilities
Ensure the accuracy and completeness of data across multiple platforms through analysis, auditing, and reporting.
Develop and maintain data integrity policies and procedures in alignment with organizational goals.
Conduct regular audits of data to identify errors, discrepancies, or missing information.
Investigate root causes of data issues and work with relevant teams to resolve them.
Generate reports on data integrity findings for internal and external stakeholders.
Keep abreast of new developments in data management and data integrity best practices.
Train staff on data integrity procedures and policies
Assist with the development and implementation of data governance framework.
Monitor compliance with data integrity policies and procedures.
Escalate non-compliance issues to senior management as needed.
Maintain up-to-date knowledge of relevant laws, regulations, and industry best practices.
Perform other duties as assigned.
Required Skills and Qualifications
Bachelor's degree in computer science, information technology, or related field
3-5 years professional experience working with Data Integrity
Experience developing and implementing data quality control processes.
Exceptional attention to detail and strong analytical skills
Ability to work independently and as part of a team.
Proficient in Microsoft Excel and Access
$49k-65k yearly est. Auto-Apply
Calibration/ Metrology Technician - Caguas
Mentor Technical Group 4.7
Caguas, PR
Calibrates electronic test measuring equipment and signal generating equipment to conform to set standards. Tests, calibrates, adjusts, and maintains electromechanical, mechanical, optical, pneumatic, hydro mechanical, and pressure-type measuring and indicating instruments. Sets up calibration sequences, methods and procedures according to detailed specifications, blueprints, drawings, and requirements. Disassembles, cleans, repairs, and replaces defective parts of test equipment such as pressure gauges and tension meters.
May monitor and verify quality in accordance with statistical process or other control procedures.
Position Responsibilities
• Performs all necessary transactions in the electronic system in order to ensure integrity of calibration/inspection data.
• Writes, modifies, and maintains procedures used for calibration activities.
• Troubleshoots and repairs equipment to restore within acceptable limits.
• Inspects fixtures, tooling and overlays as per the established procedures.
• Supports product transfers and new implementations.
• Assists in the investigations of quality issues and non-conforming situations as required.
• Prepares and presents trend data pertaining to the calibration area during monthly Quality Review meetings.
• Assists in gathering of information during FDA inspections, Notified Body Audits, Corporate Audits, etc. Performs other position related duties as assigned.
Minimum Education Associate Degree or 60 undergraduate approved credits as equivalent
Basic Qualifications Background
• Educational: Industrial Technology, Instrumentation, Electronics or related field
• Experience:
o Associate Level: 0 Years with Diploma/ Degree
o Intermediate Level: 3+ Years with Diploma/ Degree or 0 Years with Advanced Diploma/ Degree
o Senior Level: 5+ Years with Diploma/ Degree or 3+ Years with Advanced Diploma/ Degree
o Principal Level: 7+ Years with Diploma/ Degree or 5+ Years with Advanced Diploma/ Degree
o Senior Principal Level: 10+ Years with Diploma/ Degree or 7+ Years with Advanced Diploma/ Degree
• Exposure to manufacturing environment
Skills
• Analytical Thinking
• Problem Solving
• Interpersonal Relations
• Quality and Results Oriented
• Computer Literate
• Basic oral and written communication skills in Spanish and English
Desired/ Preferred
Qualifications Background
• Experience in medical device, pharmaceutical, or electronic industry
• Ability to understand and apply industrial standards in metrology and calibration for temperature, humidity, pressure/ vacuum, electronic and dimensional equipment
• Knowledge of standards and regulatory requirements applicable to calibration activities
• Certified Calibration Technician from approved college
• Experience in the development of calibration/inspection work instructions
Skills
• Teamwork
• Communications
• Continues Improvement
• Project Management
The candidates need to have experience and expertise in the following skills;
• Vision systems routines configurations in CMM and Smart Scopes “OGPs”.
• Process and Software Validations.
• GDT Knowledge.
• Expert in drawings specifications readings and interpretation.
• Available to work overtime and weekends shifts.
• English and Spanish Language.
• Available to travel.
Quality Responsibilities
•Reports any observed or informed process and/or product non-conformities to the Supervisor.
•Finds resolution of Quality Situations at the area of responsibility.
•Reports any complaint regarding a Medtronic product to the Supervisor.
•Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR's).
EHS Responsibilities
Acknowledge and maintain commitment with the EHS Policy.
•Participate in the development of EHS improvement projects.
•Participate actively in the EHS programs to achieve the objectives and targets defined for the area.
Engineers in Projects: (if apply)
•Ensure that the EHS considerations, legal and corporate requirements and efficiency indicators are included in new project design and project evaluation in order to maximize the cost/benefit ratio and minimize the EHS impacts and risks.
•Ensure that EHS performance indicators are included in the selection process of contractors.
•Evaluate and re-evaluate periodically the EHS performance of contractors and sub-contractors.
•Supervise that contractors perform their job in accordance to the EHS requirements in order to reduce, minimize or prevent EHS impacts and risks.
•Maintain current knowledge of the potential EHS aspects and risks of new projects.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
$79k-104k yearly est. Auto-Apply
Commissioning & Qualification Lead - Upstream & Downstream Process Equipment LL05-250822
Validation & Engineering Group
Gurabo, 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:
CQV Lead - Upstream & Downstream Biotech Process Equipment
The CQV Lead will be responsible for overseeing all commissioning, qualification, and validation activities related to upstream and downstream process equipment in a biotech GMP manufacturing facility. This includes strategic planning, resource coordination, protocol development, execution oversight, and stakeholder engagement across the CQV lifecycle. The role requires a strong technical background in cell culture and purification systems, as well as leadership experience in cross-functional environments supporting project delivery, regulatory compliance, and schedule milestones.
Key Responsibilities:
Leadership & Project Management
Lead CQV efforts for upstream and downstream equipment, ensuring alignment with overall project schedule and quality standards.
Manage CQV engineers and contractors; assign responsibilities and oversee protocol development and execution activities.
Represent CQV function in cross-functional meetings with QA, Manufacturing, Automation, Process Engineering, and Project Controls.
Develop CQV strategy, work plans, and schedules in alignment with URS, risk assessments, and cGMP expectations.
Support the resolution of deviations, non-conformances, and issues identified during commissioning and qualification.
Documentation & Execution Oversight
Oversee the preparation and approval of commissioning plans, IQ/OQ/PQ protocols, risk assessments, and summary reports.
Ensure traceability from URS to qualification deliverables (RTM).
Approve system walkdowns, punchlist resolutions, and impact assessments.
Lead or support FAT/SAT coordination and vendor engagements.
Compliance & Quality Assurance
Ensure CQV activities are conducted in accordance with FDA, EMA, ICH Q8-Q10, ISPE Baseline Guide Vol. 5, and ASTM E2500.
Collaborate with QA to ensure timely approvals of protocols and reports.
Ensure all validation deliverables support readiness for regulatory inspections and PPQ readiness.
Equipment in Scope:
Upstream Systems:
Bioreactors (single-use and stainless steel)
Media preparation systems and skids
Cell culture support equipment (incubators, mixing tanks)
Control systems for pH, DO, temperature, agitation
Seed train and expansion systems
Downstream Systems:
Chromatography systems (Protein A, IEX, etc.)
Tangential flow filtration (TFF) skids
Virus filtration/inactivation systems
Centrifuges and depth filtration units
Bulk hold tanks and transfer skids
CIP/SIP systems interfacing with both upstream and downstream trains
Qualifications:
Bachelor's or Master's degree in Engineering, Biotechnology, or related Life Sciences field.
Minimum 7-10 years of CQV experience in GMP biopharmaceutical manufacturing.
Demonstrated experience leading CQV teams in facility startups, tech transfers, or capital projects.
Strong technical knowledge of both upstream (cell culture) and downstream (purification) processes.
In-depth understanding of validation lifecycle and GMP documentation.
Excellent communication, coordination, and problem-solving skills.
Preferred Experience:
Use of electronic validation platforms (e.g., Kneat, Valgenesis).
Familiarity with DeltaV, Rockwell, or Siemens PCS automation.
Previous experience on large-scale biotech capital projects (greenfield/brownfield).
Experience interfacing with Quality Assurance and regulatory auditors.
$25k-44k yearly est.
Proposal Engineer Assistant
CMA Architects & Engineers
Guaynabo, PR
Responsible for the preparation, review, and coordination of technical and administrative documents required to participate in public and private bidding processes. The Proposal Engineer Assistant ensures full compliance with the requirements set forth in tender documents and guarantees timely delivery of competitive proposals. As an engineer, this role must ensure that the technical aspects of each bid are solid, feasible, and aligned with the company's capabilities.
Key Responsibilities:
Analyze technical and administrative requirements of public and private tender documents.
Coordinate the collection and drafting of technical, economic, and legal documentation for each proposal.
Prepare technical reports, execution schedules, work methodologies, risk analyses, and other required technical documents.
Collaborate with engineering, operations, legal, finance, and commercial teams to consolidate each proposal.
Ensure that proposals comply with all formal and technical requirements.
Monitor the status of ongoing bids and maintain updated records of submitted proposals.
Attend clarification meetings or technical site visits when required.
Contribute to the continuous improvement of the proposal preparation process.
Requirements:
Bachelor's degree in civil, Industrial, Electrical, Mechanical, Environmental Engineering, or a related field.
2-4 years of experience in preparing technical proposals for bidding processes. Project or site experience is a plus.
Knowledge:
Public and private procurement regulations (according to country).
Technical writing.
Advanced proficiency in MS Office (Word, Excel, PowerPoint) and engineering software (AutoCAD).
Skills:
Strong organizational skills and attention to detail.
Analytical and synthesis capabilities.
Ability to work under pressure and meet tight deadlines.
Effective communication and teamwork.