Customer Service Agent, Warehouse
Carolina, PR
FRAUD ALERT: Please note that DSV will never request a chat interview or solicit funds from applicants or employees through its interviewing and hiring process. We do not require any form of payment and will not ask for personal financial information, such as credit card or bank account number. Our recruiters have an @dsv.com or @us.dsv.com email address. If you question the legitimacy of any DSV job posting, please reach out to *************.
DSV - Global transport and logistics
In 1976, ten independent hauliers joined forces and founded DSV in Denmark. Since then, DSV has evolved to become the world's 3rd largest supplier of global solutions within transport and logistics. Today, we add value to our customers' entire supply chain by transporting, storing, packaging, re-packaging, processing and clearing all types of goods. We work every day from our many offices in more than 80 countries to ensure a steady supply of goods to production lines, outlets, stores and consumers all over the world. Our reach is global yet our presence is local and close to our customers. Read more at ***********
Location: PRI - Carolina, Lot 3-4C A Street
Division: Air & Sea
Job Posting Title: Customer Service Agent, Warehouse
Time Type: Full Time
Summary
As a Warehouse Customer Service Agent at DSV, you'll play a pivotal role in ensuring customer satisfaction by effectively addressing inquiries, resolving issues, and providing support related to warehouse operations. Your primary responsibility will be to serve as the main point of contact for customers, providing exceptional service and fostering positive relationships.
Duties and Responsibilities
Respond promptly and professionally to customer inquiries via phone, email, or in-person visits.
Provide accurate information regarding order status, inventory availability, and shipping schedules.
Investigate and resolve customer complaints, concerns, and discrepancies in a timely manner.
Collaborate with internal teams to address customer issues effectively.
Assist customers with placing orders, tracking shipments, and processing returns or exchanges.
Ensure orders are accurately entered into the system and fulfilled according to customer specifications.
Maintain accurate records of customer interactions, transactions, and inquiries.
Generate reports and summaries as needed to track customer service metrics and performance.
Identify root causes of customer issues and implement solutions to prevent recurrence.
Proactively address potential problems to ensure a seamless customer experience.
Develop a deep understanding of DSV's warehouse services, capabilities, and offerings.
Educate customers on product features, benefits, and value propositions.
Collaborate with warehouse operations, logistics, and sales teams to coordinate customer orders and requests.
Communicate customer feedback and insights to relevant stakeholders for continuous improvement.
Strive to exceed customer expectations by delivering exceptional service and building strong relationships.
Solicit feedback from customers and implement enhancements to improve overall satisfaction.
Educational background / Work experience
Some college coursework or a degree in business administration, logistics, or a related field is preferred.
2-3 years of experience in customer service roles, preferably in the transportation, logistics, or warehousing industry.
Experience with warehouse management systems (WMS) or customer relationship management (CRM) software is advantageous.
Skills & Competencies
Strong interpersonal and communication skills, both verbal and written.
Ability to multitask, prioritize tasks, and manage time effectively in a fast-paced environment.
Problem-solving and conflict resolution skills.
Attention to detail and accuracy in data entry and record-keeping.
Familiarity with Microsoft Office suite (Word, Excel, Outlook).
Preferred Qualifications
Experience in warehouse or logistics operations.
Knowledge of transportation and supply chain management concepts.
Certification or training in customer service or related areas.
Language skills
Fluent in English (oral and written)
Computer Literacy
Proficient in using computer systems, including warehouse management systems (WMS) and customer relationship management (CRM) software.
Familiarity with Microsoft Office suite and other business software applications.
At Will Employment
DSV Air & Sea Inc. employees are hired for an undefined period of time as “at will” employees. This means that an employee may be terminated for any reason, or no reason at all, at any time, provided the discharge does not violate any law*. Additionally, each employee has the right to terminate his/her employment at any time. *Except if employed in Montana, where termination requires just cause.
For this position, the expected base pay is: $13.50 - $18.25 / Hourly. Actual compensation will be determined based on job-related factors, including relevant experience, skills, education or certifications, and geographic location, consistent with applicable laws and company policy.
DSV does not accept unsolicited agency resumes. Please do not forward unsolicited resumes to our website, employees, or Human Resources. DSV will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of DSV and will be processed accordingly without fees.
DSV is an equal employment opportunity employer. Candidates are considered for employment without regard to race, creed, color, national origin, age, sex, religion, ancestry, disability, veteran status, marital status, gender identity, sexual orientation, national origin, or any other characteristic protected by applicable federal, state or local law. If you require special assistance or accommodation while seeking employment with DSV, please contact Human Resources at *************. If you are interested in learning the status of your application, please note you will be contacted directly by the appropriate human resources contact person if you are selected for further consideration. DSV reserves the right to defer or close a vacancy at any time.
DSV - Global transport and logistics
Working at DSV means playing in a different league.
As a global leader in transport and logistics, we have been on an extraordinary journey of growth. Let's grow together as we continue to innovate, digitalise and build on our achievements.
With close to 160,000 colleagues in over 90 countries, we work every day to offer solid services and meet our customers' needs and help them achieve their goals. We know that the best way to achieve this is by bringing in new talent, fresh perspectives and ambitious individuals like you.
At DSV, performance is in our DNA. We don't just work - we aim to shape the future of logistics. This ambition fuels a dynamic environment built on collaboration with world-class team players, accountability and action. We value inclusivity, embrace different cultures and respect the dignity and rights of every individual. If you want to make an impact, be trusted by customers and grow your career in a forward-thinking company - this is the place to be.
Start here. Go anywhere
Visit dsv.com and follow us on LinkedIn and Facebook.
Easy ApplySeasonal Retail Sales Associate - Plaza Palma Real
Humacao, PR
We're hiring for the holidays! Earn extra cash this holiday season and enjoy a 50% discount at our family of brands.* As a member of our team, there's even more in store for you, including access to health care options and mental health + well-being programs and exclusive discounts on some of life's expenses. Whether you're looking for a part-time job, your first job, or the next chapter in your career, we have the opportunity you're looking for.
* Applicable to regular-priced merchandise at Gap, Banana Republic, Old Navy and Athleta, and 30% off at Outlet.
About Old Navy
Forget what you know about old-school industry rules. When you work at Old Navy, you're choosing a different path. From day one, we've been on a mission to democratize fashion and make shopping fun again. Our teams make style accessible to everyone, creating high-quality, must-have fashion essentials for the whole family, with love, season after season.
We opened our first store in 1994 in San Francisco and have been on a roll ever since. We cultivate a community of playful personalities that thrive in a fast-paced environment where our employees can be their most authentic selves. Here, we're family.
About the Role
As a Brand Associate, you're an integral part of our team and bring our brand to life for our customers. You're responsible for engaging and connecting with our customers by providing excellent customer service resulting in brand loyalty. You're an expert in product and use your knowledge and experience to educate, inform, inspire and wardrobe the customer. Through collaboration with your leadership team, you'll deliver a best-in-class customer experience using an omni-channel approach. .
What You'll Do
* Consistently treat all customers and employees with respect and contribute to a positive work environment.
* Promote loyalty by educating customers about our loyalty programs.
* Seek out and engage with customers to drive sales and service using suggestive selling.
* Enhance customer experience using all omnichannel offerings.
* Be accountable to personal goals which contribute to overall store goals and results.
* Support sales floor, fitting room, cash wrap, back of house, as required.
* Maintain a neat, clean and organized work center.
* Handle all customer interactions and potential issueseturns courteously and professionally.
* Execute operational processes effectively and efficiently.
Who You Are
* A good communicator with the ability to effectively interact with customers and your team to meet goals.
* A customer-focused service provider both on and off the sales floor to help deliver an exceptional experience for our customers.
* Passionate about retail and thrive in a fastpaced environment.
* A problem solver with a focus on continuous improvement, who is always learning, open to feedback and takes action as required.
* Agreeable to work a flexible schedule to meet the needs of the business, including holiday, evening, overnight and weekend shifts.
* Able to utilize retail technology.
* Able to maneuver around sales floor, stockroom and office and lift up to 30 lbs.
Gap Inc. is an equal-opportunity employer and is committed to providing a workplace free from harassment and discrimination. We are committed to recruiting, hiring, training and promoting qualified people of all backgrounds, and make all employment decisions without regard to any protected status. We have received numerous awards for our long-held commitment to equality and will continue to foster a diverse and inclusive environment of belonging. In 2022, we were recognized by Forbes as one of the World's Best Employers and one of the Best Employers for Diversity.
LL02-251008 TOP Documentation Specialist
Juncos, PR
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 sites 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 Bachelors 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.
Margaritaville Guest Room Attendant
Ro Grande, PR
Job Description
Thank you for your interest in the Margaritaville Room Attendant position. While we may not be actively filling this specific role right now, we at Wyndham Grand Rio Mar are always eager to connect with talented individuals who share our passion for hospitality. By applying, you'll join our exclusive talent network, ensuring you're among the first to be considered when the right opportunity arises within our team. We believe in building lasting relationships and look forward to learning more about how your skills and aspirations align with our future needs. Together, let's create unforgettable experiences and build a career you'll be proud of.
Job Summary
The Room Attendant is responsible for maintaining clean and attractive guestrooms while providing attentive, courteous and efficient service to all guests.
Education & Experience
High School diploma or equivalent and/or experience in a hotel or a related field preferred.
Physical Requirements
Flexible and long hours sometimes required. Medium work - Exerting up to 50 pounds of force occasionally, and/or 20 pounds of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
Ability to stand during entire shift.
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
Conduct work in accordance with established Health and Safety regulations including the assessment of risk relating to the work being undertaken.
Work under supervision following verbal instructions executing general repair work on buildings, mechanical, electrical systems and equipment.
Perform highly skilled repair activities of facilities systems.
Deal with the general upkeep of the interior by painting and decorating.
Diagnose problems and make recommendations.
Repair and replace damaged parts and equipment such as sanitary devices and kitchen equipment.
Be capable of using high pressure water machines, generators and portable tools.
Read blueprints, floor plans and wiring diagrams.
Assist with the movement and reinstatement of equipment and fixtures as required on site such as doors, tiles and windows.
Assist in the erection and dismantling of items, fittings and equipment.
Ensure that supplies, equipment etc, are moved or relocated in a safe and effective manner.
Other duties as assigned by supervisor.
Qualifications Requirements/Knowledge/Education/Skills:
Technical College Degree preferred.
High school diploma with 2+ years of Facilities experience required or any equivalent combination of education, training, and experience which provides the requisite knowledge, skills, and abilities for this job.
Driver's license of PR
Physical Requirements and Working Environment:
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell. The employee may lift and/or move up to 25-35 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.
He / she may frequently work inside weather conditions, near moving mechanical parts, exposed to wet and or humid conditions, and an odorous atmosphere, may be exposed to fumes and the risk of electrical shock, and occasionally work on ladders in high places, in small spaces, such as lift/metering stations, manholes, tanks and wet wells. The noise level in the work environment is usually moderately loud.
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.
Auto-ApplyHealth Sciences Coordinator - Educational Institution
Carolina, PR
The Health Sciences Coordinator plays a vital role in managing and coordinating academic programs related to health sciences in an educational institution, such as universities, technical colleges, or health training institutions. This role involves overseeing and supporting faculty, students, and educational programs in fields such as medicine, nursing, physical therapy, dentistry, among others.
Key Responsibilities:
Academic Program Supervision: Coordinate and supervise health sciences academic programs, ensuring they meet quality standards and are updated in line with best practices and advancements in the field.
Resource Management: Manage the human and material resources necessary for the efficient operation of programs, including assigning faculty, budget management, and ensuring facilities are suitable for teaching.
Curriculum Development: Participate in the constant review and updating of curricula and training programs, incorporating the latest advancements in health sciences and maintaining academic relevance.
Assessment and Accreditation: Collaborate in the accreditation process for health sciences programs and faculties, complying with standards and regulations established by relevant authorities.
Personnel Management: Supervise and evaluate teaching and administrative staff, providing guidance, training, and support for the professional development of team members.
Interdepartmental Coordination: Collaborate with other academic and administrative departments to ensure efficiency and consistency in the management of health sciences programs.
Record Maintenance: Maintain accurate and up-to-date records related to academic management and program administration.
Job Requirements:
Master's degree in a field related to health sciences (e.g., medicine, nursing, physical therapy).
Previous experience in coordinating academic programs in health sciences.
In-depth knowledge of standards and regulations in the field of health education.
Leadership, management, communication, and conflict resolution skills.
Ability to work collaboratively with different departments and stakeholders.
Up-to-date knowledge in the field of health sciences.
Proficiency in MS Office.
Fluency in the English language.
Monday to Friday (9:00am - 6:00pm / 10:00am - 7:00pm / 11:00am - 8:00pm)
Auto-ApplyInventory Specialist
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.
Director of Revenue
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.
Jt130 - Calibration/Metrology Tech I
Juncos, PR
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
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.
Qualifications:
Associate degree related to Metrology Education
Requires minimum of 2 years of experience
Experience in GD&T
Experience in CMM (Coordinate Measuring Machine) such as Hexagon, Zeis and others
Knowledge in programming recipes for CMM.
Shift: 1st shift (Mon - Fri)
Quality Consulting Group, LLC 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.
Auto-ApplyCommissioning & Qualification Lead - Upstream & Downstream Process Equipment LL05-250822
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.
Data Integrity Specialist
Gurabo, PR
Job Description
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
Service Sales Consultant
Carolina, PR
About NCR Atleos
NCR Atleos, headquartered in Atlanta, is a leader in expanding financial access. Our dedicated 20,000 employees optimize the branch, improve operational efficiency and maximize self-service availability for financial institutions and retailers across the globe. NCR Atleos was ranked #12 in Newsweek's prestigious 2025 Top 100 Global Most Loved Workplaces list.
The Telecom & Technology (T&T) business of NCR Atleos is a global provider of managed network services, supporting telecom companies, network technology OEMs, and enterprises in over 160 countries. T&T offers comprehensive services, including field services, remote services, professional services, and technology lifecycle services across various domains, such as LAN/WAN, wireless, SD-WAN/SASE, optical networking, and data centers. The business supports more than 100 OEM brands and delivers exceptional services to over 200 clients globally.
The Sales Consultant will be selling solutions and services to secure new opportunities globally within targeted accounts, maximizing revenue and profitability and increasing NCR Atleos's market share; executes the sales process by moving new opportunities successfully through the funnel.
The primary focus is on strategic partnerships, account planning and opportunity planning to grow service solution and services business, while targeting global accounts at senior and executive levels and securing funding for future initiatives at the executive level
Key Responsibilities:
• Accountable for building relationships with prospective and competitive customers
• Serve as key interface in defining customer needs and NCR Atleos's ability to meet those needs through solutions
• Serve as the liaison between the customer and NCR Atleos for customer escalating any roadblocks to securing the business
• Responsible for the profitable sales of NCR Atleos services portfolio
• Regional and Cultural Understanding of customary business practices and procedures in Europe, Asia and Americas.
• Deploy, direct, and execute winning sales opportunities
• Effectively advise customers through consultative selling techniques
• Ensure the timely update of the sales funnel; Analyze creation of solution offer and proposal development
• Utilize team members including post-sale delivery professional, pre-sale technical professionals, and management to achieve business objectives
• Manage the efforts and funnel of the global sales team and directing their selling efforts as it pertains to the account strategy.
• Collaborate regionally in support of the Global Account by providing overall Account Strategy and Solution Direction
• Responsible for the profitable sales of NCR Atleos services portfolio
• Strong prospecting skills, ability to build customer relationships through consultative selling and promoting customer confidence in NCR Atleos, allowing us to build long term business relationships
• Articulate solutions in terms of ROI to the client
Basic Qualifications:
• 7 years of sales experience selling service in the high technology industry, including networking and data center.
• Expertise and practical experience in the Technology OEM markets for networking, infrastructure and security.
• Ability to work in a Matrixed environment with ability to communicate up to the “C” level executives
• Able to travel up to 40%
• Bachelor Degree or equivalent experience
#LI-CB1
#LI-remote
Offers of employment are conditional upon passage of screening criteria applicable to the job.
Full time employee benefits include:
Medical Insurance
Dental Insurance
Life Insurance
Vision Insurance
Short/Long Term Disability
Paid Vacation
401k
EEO Statement
NCR Atleos is an equal-opportunity employer. It is NCR Atleos policy to hire, train, promote, and pay associates based on their job-related qualifications, ability, and performance, without regard to race, color, creed, religion, national origin, citizenship status, sex, sexual orientation, gender identity/expression, pregnancy, marital status, age, mental or physical disability, genetic information, medical condition, military or veteran status, or any other factor protected by law.
Statement to Third Party Agencies
To ALL recruitment agencies: NCR Atleos only accepts resumes from agencies on the NCR Atleos preferred supplier list. Please do not forward resumes to our applicant tracking system, NCR Atleos employees, or any NCR Atleos facility. NCR Atleos is not responsible for any fees or charges associated with unsolicited resumes.
Auto-ApplyProject Coordinator IV
Juncos, PR
Project Coordinator will be responsible for supporting various projects, managing procurement processes, coordinating with different departments, and leading community activities. The ideal candidate will have strong communication and organizational skills, as well as the ability to adapt to changing project needs.
Responsibilities:
Create and place purchase orders.
Support special projects.
Create payment requests and support accounts payable for Puerto Rico activities.
Create and manage supplier relationships.
Schedule transportation and other travel arrangements.
Provide support to IT, Facilities, and HR functions.
Lead and coordinate activities with the Communities.
Perform other ad hoc activities as required.
Requirements Minimum of 6 years of experience in a similar role or equivalent.
Fluent in English, both speaking and writing. Dedicated and detail\-oriente.
Willing to work 100% On\-site.
Skills:
Communication skills: Interact effectively with project managers, sponsors, stakeholders, and project teams.
Problem\-solving skills: Quickly develop solutions and strategies for various issues and challenges.
Change management skills: Adapt to changes in project plans and manage variables effectively.
Organizational skills: Exhibit strong time management, delegation, planning, and decision\-making abilities.
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Utilities Technician
Juncos, PR
For utility services in the manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
Associate Degree with two (2) years of experience in industrial mechanics within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project Management skills.
Shift: 12-hour rotational shift, and according to business needs.
5:00 PM - 5:00 AM
5:00 AM - 5:00 PM
Experience in:
Preventive maintenance
HVAC, pumps, Utilities, and HEPA certification
The Personality Part:
If you have excellent communication skills and aren't afraid to ask for help when you need it (in addition to your excellent Maintenance skills), this might be the job for you! Sprinkle on a love of the scientific method, teamwork, and, above all else, being ethical, and you just might have what it takes to take on this new challenge. Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Execute intermediate maintenance activities or operate and monitor plant support equipment, referring to complex issues or problems.
Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team is responsible for.
Perform various "Housekeeping " activities (e.g., keeping work areas clean, cleaning equipment, etc.).
Ensure that operational log paperwork, daily log files, and work order documentation are completed with accurate information.
Provide a detailed training program to develop one's knowledge in the maintenance and operations field and other plant areas.
Maintain an up-to-date cGMP training book.
Develop, revise, and review related SOPs or job plans/work plans for work-related areas.
Assist in the evaluation of the current maintenance procedures and recommend changes to optimize the maintenance program.
Perform intermediate troubleshooting of utility, process, and HVAC-related equipment/ systems.
Plan and schedule own work activities with operations staff to minimize impact on production activities.
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?
Auto-ApplyCasino Dealer
Ro Grande, PR
Job Description
Thank you for your interest in the Casino Dealer position. While we may not be actively filling this specific role right now, we at Wyndham Grand Rio Mar are always eager to connect with talented individuals who share our passion for hospitality. By applying, you'll join our exclusive talent network, ensuring you're among the first to be considered when the right opportunity arises within our team. We believe in building lasting relationships and look forward to learning more about how your skills and aspirations align with our future needs. Together, let's create unforgettable experiences and build a career you'll be proud of.
Job Summary
The Casino Dealer brings valuable experience in expertly operating table games such as Blackjack, Roulette, and/or Craps, delivering professional, friendly, and engaging service that enhances every guest's visit. Skilled in reading guest needs and creating a welcoming atmosphere, the dealer builds rapport, ensures clear communication, and anticipates player questions or concerns to provide a seamless and enjoyable gaming experience. With a deep understanding of gaming regulations and a commitment to fair play, the dealer maintains trust and confidence while managing the flow of the game efficiently. This role requires strong mathematical abilities, proven customer service skills, and the ability to remain calm, focused, and approachable in fast-paced, high-pressure environments.
Education & Experience
• High school diploma or equivalent required.
• Bilingual proficiency (English and Spanish) is mandatory.
• Must possess or be eligible to obtain a valid Dealer License issued by the Puerto Rico Gaming Commission.
• Successful completion of an accredited dealer training course.
• Thorough knowledge of casino rules, regulations, and operational procedures.
Skills & Competencies
• Has the ability to act with integrity, transparency, and fairness, ensuring full compliance with gaming rules and regulations.
• Can demonstrate excellent interpersonal skills to create a welcoming and joyful environment for guests.
• Can stay calm, patient, and composed during stressful or challenging situations.
• Has the ability to work well in a team, cooperating with supervisors and colleagues to ensure smooth operations.
• Can handle confidential information with a high level of responsibility, reliability, and discretion.
• Has the ability to perform quick and accurate mathematical calculations.
Physical Requirements
• Ability to stand during long periods.
• Capability to perform repetitive hand and arm movements, such as shuffling and dealing cards.
• Good manual dexterity and hand-eye coordination.
• Ability to maintain alertness and focus in a busy, often noisy environment.
• Flexibility to work varying shifts, including nights, weekends, holidays, and sometimes long hours.
• Light work - Exerting up to 20 pounds of force occasionally, and/or 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects.
Environmental Coordinator
Humacao, PR
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
Create Environmental reports.
Conduct inspections and enforce adherence to laws and regulations governing the health and safety of individuals.
Implement and evaluate programs designed to limit chemical, physical, biological, and ergonomic risks to workers.
Participate in SEPC reviews, routine environmental inspections, audits, assessments, and incident investigations, making appropriate recommendations.
Conduct audits at hazardous waste sites or industrial sites and participate in hazardous waste site investigations.
Conduct environmental training and education programs and demonstrate the use of safety equipment.
Coordinate "right-to-know" programs regarding hazardous chemicals and other substances.
Inspect and evaluate workplace environments, equipment, and practices, to ensure compliance with safety standards and government regulations.
Examines credentials, licenses, or permits to ensure compliance with licensing requirements.
Prepare Construction Permits, Air Permits and Título V applications.
Verify Air Emissions data and calculations
Prepare necessary emissions assumptions and calculations to support permitting and regulatory compliance
Implement strategies for air condensers monitoring
Validation of tanks throughput tanks data
Projects Inspections
Other responsibilities as assigned by supervisor/management, and/or client.
Requirements/Education:
Technical College Science Degree as a minimum
BS / BA in Sciences/Environmental or related fields preferred.
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.
Auto-ApplyAssistant Manager - Plaza Escorial
Carolina, PR
About Old Navy Forget what you know about old-school industry rules. When you work at Old Navy, you're choosing a different path. From day one, we've been on a mission to democratize fashion and make shopping fun again. Our teams make style accessible to everyone, creating high-quality, must-have fashion essentials for the whole family, with love, season after season.
We opened our first store in 1994 in San Francisco and have been on a roll ever since. We cultivate a community of playful personalities that thrive in a fast-paced environment where our employees can be their most authentic selves. Here, we're family.
About the Role
As an Assistant Manager, you set the tone for the store and the team and help bring our brand to life for our customers. You're responsible for driving profitable sales growth through all aspects of the store including; customer and product operations, merchandising, and talent development. You are responsible for supporting the execution of the store strategy to achieve performance goals. Through collaboration with your General Manager and/or Assistant General Manager, you will teach and coach behaviors to Leads, Experts and Brand Associates to cultivate a high performing team to deliver a best-in-class experience to our customers.
What You'll Do
* Support strategies and processes to drive store sales and deliver results through a customer centric mindset.
* Recruit, hire and develop highly productive Brand Associate and Expert teams.
* Own assigned area of responsibility.
* Implement action plans to maximize efficiencies and productivity.
* Perform Service Leader duties.
* Ensure consistent execution of standard operating procedures.
* Represent the brand and understand the competition and retail landscape.
* Promote community involvement.
* Leverage omni-channel to deliver a frictionless customer experience.
* Ensure all compliance standards are met.
Who You Are
* A current or former retail employee with 1-3 years of retail management experience.
* A high school graduate or equivalent.
* A good communicator with the ability to effectively interact with customers and your team to meet goals.
* Passionate about retail and thrive in a fastpaced environment.
* Driven by metrics to deliver results to meet business goals.
* Determined to effectively lead and inspire others to learn and grow through coaching and mentoring.
* Agreeable to work a flexible schedule to meet the needs of the business, including holiday, evening, overnight and weekend shifts.
* Able to utilize retail technology. • Able to maneuver around the sales floor, stockroom and office and lift up to 30 pounds.
* Ability to travel as required.
Benefits at Old Navy
* Merchandise discount for our brands: 50% off regular-priced merchandise at Old Navy, Gap, Banana Republic and Athleta, and 30% off at Outlet for all employees.
* One of the most competitive Paid Time Off plans in the industry.*
* Employees can take up to five "on the clock" hours each month to volunteer at a charity of their choice.*
* Extensive 401(k) plan with company matching for contributions up to four percent of an employee's base pay.*
* Employee stock purchase plan.*
* Medical, dental, vision and life insurance.*
* See more of the benefits we offer.
* For eligible employees
Gap Inc. is an equal-opportunity employer and is committed to providing a workplace free from harassment and discrimination. We are committed to recruiting, hiring, training and promoting qualified people of all backgrounds, and make all employment decisions without regard to any protected status. We have received numerous awards for our long-held commitment to equality and will continue to foster a diverse and inclusive environment of belonging. In 2022, we were recognized by Forbes as one of the World's Best Employers and one of the Best Employers for Diversity.
Director of Housekeeping
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
Job Description
The Director of Housekeeping is responsible for leading the hotel's housekeeping department, ensuring that all areas-including guest rooms, public spaces, and back-of-house-are maintained in immaculate condition and meet Fairmont's highest standards of cleanliness and presentation. This key role directly contributes to the guest experience, ensuring a memorable, elegant, and flawlessly maintained stay.
The person in this role will be a proactive and detail-oriented leader capable of motivating, training, and supervising a diverse team, while fostering a culture of operational excellence, mutual respect, and genuine hospitality. Additionally, the Executive Housekeeper will work closely with other departments to deliver integrated and efficient service, ensuring all guest requests are handled promptly and professionally.
Qualifications
QUALIFICATION STANDARDS
EDUCATION & SKILLS
College degree preferred with emphasis in Hospitality
Ability to speak English and Spanish
Proficiency in relevant software, including Microsoft Outlook, Microsoft Office, Opera, and property management systems (PMS).
EXPERIENCE
Minimum of 5 years of relevant experience in the hotel industry, preferably in housekeeping management within luxury (5-star) hotels.
Additional Information
Our commitment to Diversity & Inclusion:
We are an inclusive company and our ambition is to attract, recruit and promote diverse talent.
LL02-251022 C&Q Lead - Inspection Lines
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:
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.
Principal Validation Engineer
Juncos, PR
For CQV services in the Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree with eight (8) years of experience as a C&Q Engineer within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project Management skills.
Shift: Administrative, and according to business needs.
Experience in:
CQV Validation Expert: Risk-based qualification methods (ASTM E 2500) for pharmaceutical manufacturing equipment and utilities
Sterilization & Cleaning Specialist (SME): CIP and SIP processes
GMP Document Controller: Validation Protocols (IQ/OQ/PQ), Risk Assessments, and leading Root Cause Analysis (RCA) for quality issues.
Engineering Project Support: P&IDs and FAT/SAT.
The Personality Part:
Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Review and/or Approve Lifecycle Documents, including but not limited to User Requirements, Risk Assessments, Data Integrity Assessments, Commissioning and Qualification Plans, Validation Plans, Installation, Operational and Performance Verification (included but not limited to Clean Utilities such as APR, WFI, SCL, and PW) protocols and reports
Support field execution of commissioning/integration testing required by the C&Q Plan.
Evaluate and approve protocol discrepancies/deviations with direct support in the Root Cause Analysis.
Review engineering change notices and evaluate/propose modifications to the qualification strategies
Participate in engineering design phases and propose strategies to assure successful qualification and start-up. Anticipate potential pitfalls based on regulatory /compliance guidance
Apply Risk-Based Validation approaches based on Amgen Standard Operating Procedures and industry guidance
Create and/or revise SIP drawings (~65) for Upstream and Downstream impacted circuits.
Participate in project weekly meetings, such as Detail Design Technical Meeting and Slowdown Window Workshops for Upstream, Downstream, and Clean Utilities.
Participate in risk assessments to identify potential hazards and implement appropriate controls, including, but not limited to, reviewing and approving the risk assessment report.
Process and Equipment understanding, which includes P&IDs walkdown with engineering and determination of impacted circuits (product/non-product contact).
Provide SME support to engineering phases, including basis of design, detailed design, risk assessments, and align the commissioning execution strategy with the CQ Service Provider (e.g., FAT, SAT, Set to Work, Safety, Maintenance, Receipt Verification, Installation Verifications, Functional Testing, etc)
Clean In Place (CIP) expertise, which includes, but is not limited to, cycle development, cleaning studies, worst case determination, protocol, and report preparation.
Steam In Place (SIP) expertise, including but not limited to Thermal, Biological Indicator, and Microbial Challenge testing to assess the effectiveness of the sterilization process and protocol, and report preparation.
Evaluates and documents the commissioning and qualification impact to proposed critical system changes through the Change Control Program, if necessary.
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?
Auto-Apply