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Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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. Employ excellent communication skills to manage internal and external relationships with external partners, site management, and cross-functional teams.

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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:<ul><li>Technical Services / Manufacturing Science Scientist</li></ul>Scope and Responsibilities:Under limited supervision and in accordance with applicable laws, federal regulations, and company policies, procedures, and guidelines, this position has the following tasks and duties:<ul><li>Provide technical oversight for spray dry, solid dosage manufacturing and packaging processes, leveraging a strong technical foundation and previous experience supporting these processes.</li><li>Participate in resolution of technical issues, including those related to control strategy and manufacturing.</li><li>Possess excellent technical writing capabilities, including authoring of deviations and change controls.</li><li>Employ excellent communication skills to manage internal and external relationships with external partners, site management, and cross-functional teams.</li><li>Build and maintain relationships with development and central technical organizations.</li><li>Ensure that manufacturing processes are compliant, capable, in control, and maintained in a validated or qualified state.</li><li>Understand, justify, and document the state of process validation with data that evaluates the capability of the manufacturing process to meet its stated purpose.</li><li>Maintain processes in a state of compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance.</li><li>Support ongoing manufacturing at External Partners through process monitoring, issue response, and process improvements where necessary.</li><li>Support technical transfer and validation activities to external partners manufacturing and packaging sites.</li><li>Work cross-functionally within the site and other functions to deliver on technical objectives.</li><li>Some flexibility may be required to support 24/7 operations and issue resolutions with external partners across different time zones.</li><li>Operate demonstrating a collaborative approach and positive attitude toward change.</li></ul>Requirements:<ul><li>Bachelor's degree (minimum) in scientific disciplines of Chemistry, Pharmacy, or Engineering.</li><li>5+ years of demonstrated hands-on working experience and proficiency with spray dry, solid dosage manufacturing and packaging.</li><li>Working knowledge of regulatory expectations (cGMPs and applicable global regulatory guidance).</li><li>Strong understanding of regulatory requirements and their application in a manufacturing environment.</li><li>Proficient in data management practices across manufacturing and packaging operations.</li><li>Proven ability to effectively communicate and influence across diverse technical and business teams.</li><li>Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects.</li><li>Demonstrates adaptability, a collaborative mindset, and a positive attitude toward change.</li><li>Available to support 24/7 operations and issue resolutions across multiple time zones as needed.</li><li>Fluent in English and Spanish, with the ability to communicate effectively across diverse teams and stakeholders.</li></ul>At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team. 
Excited to build something meaningful together? We look forward to hearing from you. 
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Validation & Engineering Group, Inc

Technical Services / Manufacturing Science Scientist

Biotech and Pharmaceutical

Change Control

Chemistry

Communication Skills

Cross-Functional

Current Good Manufacturing Practice (cGMP)

Data Analysis

Data Management

Data Processing

Documentation

English Language

Healthcare

Manufacturing

Manufacturing Operations

Manufacturing Requirements

Manufacturing/Industrial Processes

Medical Equipment

Pharmacy

Problem Solving Skills

Process Improvement

Process Validation

Project/Program Management

Public/Media/Press/Analyst Relations

Regulations

Regulatory Requirements

Spanish Language

Team Lead/Manager

Team Player

Technical Delivery

Technical Support

Technical Writing

Writing Skills

clearcompany

The Medical Science Liaison engages in scientific exchange with medical and scientific experts, including Healthcare Professionals and Managed Markets Customers; helps to identify pre-clinical, clinical and post-marketing study investigators in alignment with corporate objectives; responds to customer inquiries to ensure focused and balanced clinical and scientific information that supports the appropriate use of products and services; delivers appropriate clinical and scientific information that clinically differentiates products; and provides clinical support and delivers data presentations regionally and nationally. Represent Organon at both national and regional medical meetings to drive awareness of Organon, support Medical Information booth activities, as needed, cultivate relationships and scientific exchange, and gain real-world insight from HCPs on data and disease area to share with internal colleagues and help inform strategy and plans.

Job DescriptionThe PositionThe Medical Science Liaison is a field-based professional with scientific, clinical and therapeutic area expertise responsible for providing medical and scientific support for Organon's Women's Health programs. The Medical Science Liaison engages in scientific exchange with medical and scientific experts, including Healthcare Professionals and Managed Markets Customers; helps to identify pre-clinical, clinical and post-marketing study investigators in alignment with corporate objectives; responds to customer inquiries to ensure focused and balanced clinical and scientific information that supports the appropriate use of products and services; delivers appropriate clinical and scientific information that clinically differentiates products; and provides clinical support and delivers data presentations regionally and nationally.Territory includes Puerto RicoResponsibilities<ul><li>Identify, develop and maintain long-term collaborative relationships with healthcare professionals (HCPs), professional organizations, patient advocacy groups, payers, decision makers and other key stakeholders in the assigned therapy area and geography.</li><li>Maintain clinical, scientific and technical expertise in Women's Health.</li><li>Present data and conduct balanced peer-to-peer scientific dialogue on Organon's products with HCPs, academic institutions, clinical investigators, and other stakeholders that is consistent with Organon's policies and procedures.</li><li>Collaborate on the development and implementation of the scientific communication plan, medical-to-medical materials, and research including facilitation of research collaborations such as investigator-initiated trials and collaboration with Clinical Development colleagues on investigator selection, relationship, and site performance/recruitment.</li><li>Assist in the scientific training for Commercial and other internal colleagues regarding products and the conditions they treat utilizing approved materials.</li><li>Provide scientific expertise and support for speaker training and advisory boards, as requested.</li><li>Represent Organon at both national and regional medical meetings to drive awareness of Organon, support Medical Information booth activities, as needed, cultivate relationships and scientific exchange, and gain real-world insight from HCPs on data and disease area to share with internal colleagues and help inform strategy and plans.</li><li>Respond to unsolicited requests for medical information while adhering to all policies and procedures regarding the provision of medical information and documentation of requests.</li></ul>Required Education, Experience and Skills<ul><li>PharmD, PhD, MD, or equivalent education.</li><li>Five years clinical practice and/or pharmaceutical industry experience.</li><li>Dermatology experience is preferred.</li><li>Ability to develop and maintain strong, collaborative, and long-term relationships with HCPs, decision makers, and organizations.</li><li>Excellent interpersonal skills in both one on one and group settings and dedicated team player.</li><li>Strong communication and presentation skills.</li><li>Demonstrated ability to identify opportunities for medical engagement and to develop and drive scientific engagement goals and objectives.</li><li>Clear understanding of clinical research methodologies and ability to independently evaluate and translate scientific material in an effective credible manner.</li><li>Ability to travel locally, regionally, and nationally up to ~50%, when appropriate.</li><li>Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development.</li><li>Desire to work in a quickly changing and fast-paced growing business.</li><li>Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done.</li><li>Ability to overcome ambiguity and challenge the status quo.</li><li>Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently.</li><li>Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders.</li></ul>Who We Are:Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.US and PR Residents OnlyFor more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA SupplementOFCCP EEO SupplementOFCCP Pay Transparency RuleOrganon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.Search Firm Representatives Please Read CarefullyOrganon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.Annualized Salary Range (US)$0.00 - $0.00Please Note: Pay Ranges are Specific to local market and therefore vary from country to countryEmployee Status:RegularRelocation:No relocationVISA Sponsorship:Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.Flexible Work Arrangements:Shift:Valid Driving License:Hazardous Material(s):Number of Openings:1

Organon & Co

Medical Science Liaison

Business Growth

Career Development

Clinical Information

Clinical Research

Clinical Support

Dermatology

Disease

Driver's License

Drug Development

Entrepreneurship

Establish Priorities

Geography

International Health

Interpersonal Skills

Managed Care

Marketing

Medical Office Administration

Medical Records

Medical Research

Medical Treatment

Pre-Clinical

Presentation/Verbal Skills

Request for Information (RFI)

Research Skills

Resume Search

Staff Requirements

State Laws and Regulations

Strategic Planning

Vaccination

Willing to Travel

Women's Health

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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. This entry-level role focuses on learning and applying validation principles, supporting risk-based assessments, and developing technical and compliance expertise in a GMP-regulated environment.

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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:<ul><li>Associate CSV – Periodic Review Scientist</li></ul>Position SummaryThe Associate CSV Periodic Review Scientist supports the execution of periodic reviews for GxP computer systems to ensure compliance with regulatory requirements and maintenance of the validated state. This entry-level role focuses on learning and applying validation principles, supporting risk-based assessments, and developing technical and compliance expertise in a GMP-regulated environment.Key Responsibilities<ul><li>Assist in the execution of Periodic Reviews (PR) for GxP computer systems under supervision.</li><li>Support the evaluation of:
	<ul><li>Change controls, deviations, and CAPAs</li><li>System maintenance and calibration status</li><li>User access reviews and audit trails</li><li>Backup and restore processes</li></ul></li><li>Help compile and organize documentation for PR reports.</li><li>Apply basic risk-based thinking to assess system status and identify potential issues.</li><li>Ensure documentation meets GDP (Good Documentation Practices) requirements.</li><li>Collaborate with cross-functional teams such as QA, IT, Engineering, and Operations.</li><li>Support audit and inspection readiness activities.</li><li>Follow procedures aligned with 21 CFR Part 11, EU Annex 11, and Data Integrity requirements.</li><li>Participate in training programs to build knowledge in CSV/CSA and GxP compliance.</li></ul>Qualifications<ul><li>Bachelor’s degree in:
	<ul><li>Engineering (any discipline)</li><li>Computer Science / Information Systems</li><li>Life Sciences (Biology, Chemistry, Microbiology)</li></ul></li></ul><ul><li>0–2 years of experience in:
	<ul><li>GMP environment, validation, IT, or quality (internships or co-ops acceptable)</li></ul></li><li>Exposure to computer systems or regulated environments is a plus</li></ul>Technical Skills<ul><li>Basic understanding (or willingness to learn):
	<ul><li>GxP regulations</li><li>Data Integrity (ALCOA+)</li><li>CSV/CSA concepts</li></ul></li><li>Familiarity with:
	<ul><li>Microsoft Office (Excel, Word, PowerPoint)</li></ul></li><li>Exposure to GxP systems (SAP, LIMS, etc.) is a plus but not required</li></ul>Preferred Qualifications<ul><li>Internship experience in pharmaceutical, biotech, or regulated industries</li><li>Basic knowledge of validation lifecycle or system documentation</li><li>Exposure to audit or compliance activities</li></ul>At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team. 
Excited to build something meaningful together? We look forward to hearing from you. 
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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Technical Services / Manufacturing Science Scientist Validation & Engineering Group, Inc

Medical Science Liaison Organon & Co

Associate CSV – Periodic Review Scientist Validation & Engineering Group, Inc

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