Jobs in Fajardo, 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 In this role, you will engage and connect with our customers by providing excellent customer service. You will be an expert in product and use this expertise to educate, inform, inspire and outfit the customer. You will offer information to the customer on current merchandise assortment, store promotions and events, and execute operational processes effectively and efficiently. Your goal is to bring our brand to life for our customers while building brand loyalty and delivering with productivity. Como asociadx de marca, eres una parte fundamental de nuestro equipo y lx encargadx de dar vida a nuestra marca ante lxs clientes. Eres responsable de interactuar y relacionarte con nuestrxs clientes brindando un excelente servicio que genere lealtad a la marca. Eres expertx en los productos y utilizas tus conocimientos y experiencia para educar, informar, inspirar y crear un guardarropa para lxs clientes. En colaboración con el equipo de liderazgo, ofrecerás la mejor experiencia para lxs cliente utilizando un enfoque omnicanal. 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 * Tratar siempre con respeto a todxs lxs clientes y empleadxs y fomentar un ambiente laboral positivo * Promover la lealtad al informar a lxs clientes sobre nuestros programas de lealtad * Interactuar con lxs clientes para impulsar las ventas y el servicio mediante el uso de ventas por sugerencia * Mejorar la experiencia de lxs cliente utilizando todas las propuestas omnicanal * Responsabilizarte por las metas personales que contribuyen a los resultados y las metas generales de la tienda * Brindar apoyo en el piso de ventas, los probadores, el área de cajas y la trastienda, según sea necesario * Mantener un lugar de trabajo limpio, ordenado y organizado * Desenvolverte con cortesía y profesionalismo en todas las interacciones con lxs clientes y al abordar posibles problemas o devoluciones * Ejecutar todos los procesos operativos de manera efectiva y eficiente 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 * Eres buenx comunicadorx con capacidad de interactuar de manera eficaz con clientes y con tu equipo para alcanzar las metas establecidas * Eres proveedorx de servicios centradx en lxs clientes tanto en el piso de ventas como fuera de esa área para ofrecer una experiencia excepcional a nuestrxs clientes * Eres una persona apasionada por el retail que prospera en un entorno vertiginoso * Solucionas problemas con un enfoque centrado en la mejora continua, siempre escuchas, estás abiertx a la retroalimentación y haces modificaciones según sea necesario * Tienes disponibilidad para trabajar en un horario flexible que se adapte a las necesidades del negocio, incluidos días festivos, turnos vespertinos, nocturnos y fines de semana * Puedes utilizar la tecnología de retail * Tienes la capacidad de desplazarte en el piso de ventas, el almacén y la oficina, y puedes levantar objetos de hasta 13 kilos (30 lb) 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.

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.

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 Saturday 2am-11am and Sundays 3pm-12am. 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.

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.

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. Requirements: Certified technician with experience working with general fixtures used in the regulated manufacturing industries (metrology). Entry level position typically requiring little to no prior experience in technical aspects of a job . Work is clearly defined, routine or follows standard procedures and is closely supervised. Performs basic tests and records data. Excellent interpersonal skills, responsible, serlf-starter, focused on self-development.

The smartphones industry is looking for a promoter to support sales and implement and maintain their promotional material and equipment in-stores. If you are passionate person, focused in customer service and sales, this opportunity is for you! Job Responsabilites: Go to the right stores following the established itinerary Manage in-store displays (maintain “perfect store” standard): keep display clean and in recommended alignment, display pop material, enhance display of iconic products, seek new in-store display opportunities, and negotiate better display areas Build strong interpersonal relationships with the store manager and salespeople Generate and submit quantitative and qualitative reports on time and accurately Transfer product knowledge and service skills to store staff Execute promotions to customers and store vendors according to the indications given by the brand Job Requirements: Proven experience in visual marketing Ability to use promotional material following the guidelines Proven experience in customer service Basic knowledge of MS Office Strong teamwork spirit Excellent communication skills Ability to work autonomously, managing your own time and schedule Accustomed to working based on objectives (KPIs) Availability to travel, own car and valid license Required Availability: Monday to Saturday 8:00am - 6:00pm Route: Municipalities you may visit: From Humacao - San Lorenzo - Juncos - Carolina - Canóvanas - Fajardo Compensation: Base pay: $13.00 per hour, full time Monthly incentives based on KPIs metrics Car allowance Cellular Service TPIS is an Equal Opportunity Employer (EEO Employer/Affirmative Action for Women/Disabled/Veterans). We comply with all federal, local and state laws regarding non-discrimination) Required Availability: Monday - Saturday 8:00am - 6:00pm

Specialist Unit Representative / NTUC Process

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. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. 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. 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.

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 Q8Q10, 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: * Bachelors or Masters degree in Engineering, Biotechnology, or related Life Sciences field. * Minimum 710 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.

Career CategoryQualityJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director, CMC Modeling & Advanced Statistics What you will do Let's do this. Let's change the world. In this vital role, you will serve as Amgen's leader in advanced statistical modeling for CMC development and commercial support. Reporting to the Senior Director, CMC Statistics, you will drive innovation in kinetic modeling, Bayesian statistics, and predictive methods to accelerate decision-making across Amgen's product portfolio. You will also ensure best-in-class application of advanced modeling techniques to CMC data, spanning drug substance, drug product, and delivery device development. As Director, CMC Modeling & Advanced Statistics, you will: Provide strategic and technical leadership in the design and implementation of kinetic modeling, Bayesian methods, and predictive analytics to support product and process characterization, stability modeling, and specification setting. Lead development and application of statistical/mathematical models to optimize manufacturing processes, evaluate product lifecycle and stability data, and support regulatory submissions. Champion the integration of Bayesian methods and modeling frameworks to enhance data utilization, manage uncertainty, and improve decision-making across the CMC lifecycle. Partner with cross-functional teams (Process Development, Analytical Sciences, Quality, Manufacturing, and Regulatory) to ensure modeling strategies are aligned with Amgen's business and scientific objectives. Contribute to regulatory strategies by developing and defending modeling-based justifications in submissions and at regulatory authority interactions. Advance Amgen's digital and data science strategy by incorporating machine learning, simulation, AI, and automation approaches into statistical workflows. Represent Amgen externally through scientific collaborations, publications, and conference presentations to establish thought leadership in CMC modeling. Train & guide other statisticians & data scientists in the use of innovative statistical approaches, including but not limited to kinetic, Bayesian, and predictive modeling What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of relevant biopharmaceutical industry experience OR Master's degree and 8 years of relevant biopharmaceutical industry experience OR Bachelor's degree and 10 years of relevant biopharmaceutical industry experience In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Degree in Statistics, Biostatistics, Applied Mathematics, Engineering, or related quantitative field. Deep expertise in kinetic modeling, Bayesian methods, and advanced statistical modeling techniques. Strong track record of applying statistical modeling to CMC data, including stability, comparability, process characterization, and analytical method development. Proficiency with statistical software (e.g., R, SAS, JMP, Minitab) and modeling tools (e.g., NONMEM, MATLAB, Stan, or similar Bayesian frameworks). Demonstrated success influencing regulatory strategies through modeling-based approaches. Proven ability to lead and develop technical talent in statistics and modeling. Excellent oral and written communication skills, with ability to explain complex modeling approaches to both technical and non-technical audiences. Experience working in cross-functional and global team environments. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 207,002.00 USD - 238,637.00 USD

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

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.

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?

Job Description Thank you for your interest in the Casino Marketing Host 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 Marketing Host is responsible for processing credit applications and updating player information while delivering a welcoming and personalized guest experience. This role supports the Credit department by accurately inputting player data and assisting with general credit-related functions. The Marketing Host must maintain up-to-date knowledge of all current marketing programs, promotions, and casino offerings to effectively inform and engage players, enhancing their overall experience and loyalty. Exceptional communication and service skills are essential in building strong relationships with guests and ensuring a high level of satisfaction. Education & Experience • High school diploma or equivalent required. • Bilingual proficiency (English and Spanish) is mandatory. • Must possess or be eligible to obtain a valid Casino License issued by the Puerto Rico Gaming Commission. • Knowledge of casino rules, regulations, and operational procedures. • Proficient computer skills required, including the use of company-approved word processing and spreadsheet software. Skills and Competencies • Has the ability to build and maintain strong guest relationships through personalized service and professional communication.. • Has strong organizational skills to manage player data, credit applications, and promotional details with accuracy and attention to detail. • Has the ability to stay informed and up to date on all current marketing campaigns, promotions, and events to proactively inform and engage guests. • Has a guest-first attitude, remaining approachable, friendly, and responsive in a fast-paced and dynamic environment. • Can manage time effectively and multitask while balancing administrative duties and guest interactions. Physical Requirements • Ability to stand during long periods. • 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.

The Senior Packaging Engineer will lead the development and implementation of packaging solutions for medical devices at BD Humacao. This role is responsible for ensuring packaging systems meet performance, regulatory, and operational requirements. The engineer will work closely with cross-functional teams to support production, drive continuous improvement, and ensure packaging integrity throughout the product lifecycle. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Key Responsibilities: * Design, develop, and validate packaging systems for medical devices, considering material compatibility, sterilization methods, and manufacturing constraints to ensure packaging solutions are robust, compliant, and cost-effective. * Provide on-site technical support for packaging processes, troubleshooting issues, and implementing corrective actions. * Conduct and document packaging testing (e.g., seal strength, integrity, transit simulation, and bioburden) in accordance with industry standards and internal protocols. * Lead packaging-related investigations, root cause analysis, and implementation of process improvements. * Support new product introductions and packaging changes through design control and change management processes. * Participate in audits, risk assessments, and validation activities related to packaging systems. * Maintain up-to-date knowledge of packaging regulations, standards (e.g., ISO 11607), and industry best practices. * Less than 10% travel may be required. Qualifications * Bachelor's degree in Packaging Engineering, Mechanical Engineering, or a related field. * Minimum of 5 years of experience in medical device packaging, preferably in a manufacturing environment. * Strong understanding of packaging materials, sterilization techniques, and regulatory requirements (e.g., FDA, ISO). * Experience working in a GMP-compliant environment. * Excellent problem-solving, communication, and organizational skills. * Proficiency in Microsoft Office and familiarity with CAD or packaging design software is a plus. Primary Work Location and Additional Considerations: * We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas at this time. * We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to provide Relocation assistance at this time. * This is a Hybrid role that requires you to be at your assigned worksite 4 days out of the week and other days from home. Local policies may apply. BD may change your work arrangement based on business needs. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work Location USA PR - Humacao Additional Locations Work Shift

Job Description Thank you for your interest in the Barback 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 Barback/Bar Apprentice supports the bartender and service team by ensuring the bar is fully stocked, clean, and operating efficiently throughout service. This role is responsible for replenishing supplies such as liquor, ice, garnishes, and glassware, assisting with inventory and keg changes, and maintaining cleanliness in all bar areas. The Barback also helps monitor guest needs at the bar, ensuring timely and friendly service in a fast-paced environment. Working closely with the bartender and other team members, the Barback plays a key role in delivering smooth operations and exceptional guest experiences. Education & Experience • High School diploma or equivalent and/or experience in a hotel or a related field preferred. • At least 1 year of experience in a restaurant setting, such as a busperson, counter attendant, or cocktail server. • General understanding of common beverages, garnishes, and bar terminology. • Strong communication, interpersonal and customer service skills. • Fully bilingual (English and Spanish). • Safety and Food Handling Certification. • Valid Alcohol Training Certification (TIPS) • Valid Health Certificate (including throat culture results) as required by the Puerto Rico Department of Health. Physical Requirements • Flexible and long hours sometimes required. • Routinely required to bend, stoop, stand, and walk for extended periods. • Heavy work - Exerting up to 100 pounds of force occasionally, and/or 50 pounds of force frequently and/or 20 pounds constantly to lift, carry, push, pull or otherwise move objects. • Must have the physical stamina and ability to work efficiently in a fast-paced, high-traffic environment.

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.

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. Qualifications Education * Bachelors 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.