Packaging Scientist (Life Sciences Industry)
Chemist job in Puerto Rico
Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has deliver proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.
DESCRIPTION
Packaging Scientist candidates must possess field Packaging experience, in the healthcare industry, preferred in solid dosages industry, medical device, pharmaceutical and/or bio-pharmaceutical.
EDUCATION
BS in Science or Engineering
5 to 7 years of experience
RESPONSIBILITIES
The resource will provide support to the packaging engineering team and will be responsible for packaging validations.
The successful candidate will also support packaging project field executions, must have the availability to work in different shifts, be able to validate/qualify equipment and systems, generate and complete validation protocols (Traceability matrix, IQ, OQ, PQ, among others).
Must possess a solid understanding of FDA validation guidelines and industry best practices for this field and be able to implement packaging validation standards on a daily basis.
Implement policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
Generate, execute, review, and complete regulatory documentation required.
Communicate with the staff and management on ways of implementing plans and recommendations.
Assure project deliverables are done in a timely manner.
REQUIREMENTS/SKILLS
Packaging validation equipment experience
Knowledge in CAPA and Compliance
Available to work in different shifts.
Willing to work overtime including weekend depending on the nature of work available.
Able to work with minimum or no supervision.
Strong interpersonal skills and must work in a team.
Basic Project Management
Fully Bilingual (English and Spanish) - REQUIRED
Ultimate Solutions Corp is an Equal Opportunity Employer
MF01-110425 Laboratory Chemist
Chemist job in Dorado, 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:
Laboratory Chemist
Qualifications:
Bachelor's Degree in Chemistry.
3-5 years of experience
Chemist License (Highly preferred)
Equipment: HPLC, UV, IR, etc.
Knowledge: Chromatography (Empower system), USP, EP, and so forth.
Available to work extended hours, possibility of weekends and holidays.
LL01-251118 Quality Control Scientist III
Chemist job in Imbry, 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:
Quality Control Scientist III
Qualifications:
Bachelor's Degree in Science.
Minimum of 8 years of experience in direct pharmaceutical quality control areas and regulatory operations.
Must be fully bilingual (English / Spanish) with excellent oral skills.
Must be proficient using MS Windows and Microsoft Office applications.
Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
Strong knowledge (according to related area).
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
Evaluate compendial changes from the different pharmacopeias.
Generate trend reports of investigations based on the company's procedures.
Evaluate global documents against site-specific procedures and update the site procedure accordingly.
Draft technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports, based on corporate policies, SOPs, compendial guidelines, ICH, DEA, and FDA regulatory guidance.
Generate required change requests for analytical documents and route documents for review and approval.
Conduct laboratory event/out-of-specification/out-of-trend investigations and close them on time.
Laboratory Technician
Chemist job in Barceloneta, PR
At **Kelly Science, Engineering, Technology & Telecom (SETT** **)** , we're passionate about helping you find a job that works for you. How about this one? We're seeking an **Laboratory Technician** to work with one of our top global biopharmaceutical clients in the **Barceloneta PR** area. With us, it's all about finding the job that's just right
Perform laboratory analytical tests on raw materials and finished products following the established parameters (company policies, FDA, cGMP) and applicable regulations without impact to the manufacturing cycle or the laboratory workflow. Follow Good Manufacturing Practices), safety rules, and Good Laboratory Practices (GLP).
**Responsibilities:**
* Responsible for performing laboratory analytical tests on the raw materials and finished products following the established parameters (Customer policies, FDA, cGMP) and applicable regulations without impact to the manufacturing cycle or the laboratory workflow.
* Document The results of the test and analysis performed accurately.
* Perform preventive maintenance and standardize the laboratory equipment.
* Participate in the implementation of special projects and test method transfers.
* Assure that all samples are collected, tested, and authorized as per the schedule and following applicable procedures.
**Qualifications**
* Associate or Bachelor degree in Science required, with a major in **Chemistry**
* A minimum of two years of experience in the pharmaceutical industry or equivalent in an analytical laboratory..
* Availability to work the third shift, ALL Shifts weekends, and holidays according to business needs.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (********************************************************************* for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Applied Scientist 4
Chemist job in San Juan, PR
Invent, implement and deploy state-of-the-art machine learning and/or specific domain industry algorithms and systems. Build prototypes and explore conceptually new solutions. Work collaboratively with science, engineering, and product teams to identify customer needs in order to create and implement solutions, promote innovation and drive model implementations. Applies data science capabilities and research findings to create and implement solutions to scale. Responsible for developing new intelligence around core products and services through applied research on behalf of our customers. Develops models, prototypes, and experiments that pave the way for innovative products and services. Build cloud services that work out of the box for enterprises, e.g. decision support, anomaly detection, forecasting and recommendations), natural language processing (NLP), Natural Language Understanding (NLU),Time Series, Automatic Speech Recognition (ASR), Machine Learning (ML), and Computer Vision (CV). Design and run experiments, research new algorithms, and find new ways of optimizing risk, profitability, and customer experience. Conversant on ethical problems in consideration of sciences.
**Responsibilities**
Leading contributor providing guidance and mentorship to define, design and deliver product quality improvements from ideation stage to shipping to the customer. Write high quality code to power experiments and build models. Contributes to writing production model code. Work closely with product management and engineering to deliver products which solves the needs of our customers by building relevant, innovative results which strategically differentiates Oracle in the market. Set up environment needed to run experiments for all projects. Set up distributed environments. Engage with customers and help solve complex problems with the customer/partner. Directly impact our customers via innovation in products and services that make use of ML/AI technology. Clearly articulate technical work to audiences of all levels and across multiple functional areas. Keep track of the progress and ensure the team is following the best practices. Works on training data collection, feature engineering, model training, offline and online experimentation. Drives independent research and development. Advance the state-of-the-art machine learning and algorithms for real-world large-scale applications. Ensure solutions are designed with fairness and explainability in mind. May perform other duties as assigned.
Disclaimer:
**Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.**
**Range and benefit information provided in this posting are specific to the stated locations only**
US: Hiring Range in USD from: $120,100 to $251,600 per annum. May be eligible for bonus, equity, and compensation deferral.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
9. 11 paid holidays
10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC4
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
QC Lab Equipment Qualification Support
Chemist job in San Juan, PR
Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, manufacturing operations among other services.
Job Description
Development and execution of Laboratory Equipment Validation. Development of Validation Plan, Risk Assessment, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs. Execution of related validation protocols. Development of documentation packages for all activities, including: Original format documents, approved document and applicable drawings.
Qualifications
Bachelor Degree in Chemistry or related discipline
Experience developing Validation Plans, Risk Assessments, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs.
Validation Experience in Computer Systems
21 CFR Part 11 practical knowledge
Strong knowledge in GMPs regulations
Technical Writing Experience
Validation expertise in:
Sterilization
Kaye Validator & Data loggers
Process Validation
Equipment Qualification
Re-qualification
Computer System Validation
Additional Information
Positions available for Puerto Rico.
Only candidates that meet the minimum requirements will be considered.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.
Scientist-TS/MS
Chemist job in Carolina, PR
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Job Overview
Provides technical support to achieve the reliable and compliant manufacture of bulk drug substance to predetermined global quality standards via a detailed set of manufacturing instructions and procedures. The candidate will serve as an expert of Contamination Control Strategy.
The candidate will be responsible for:
* Definition and implementation of the routine environment monitoring plan and ensure that such plan is aligned with the Contamination Control Strategy (CCS)and thus the process remains in control and capable.
* Provide technical support to operational staff in terms of Environmental Monitoring (EM), Sanitization, CCS and Cleaning programs.
* Primary responsible for proactively detecting any CCS related data variability and identifying/implementing actions as response to it.
* Contributing to the improvement agenda.
* Performing periodic evaluations for Environmental Monitoring and generating reports to analyze system performance.
* Technical documentation of the CCS program in official sources such as: Process Flow Diagrams (PFDs), Quality Risk Assessments, manufacturing instructions, SOP's and technical reports.
* Participate in the design and execution of Process, Cleaning, Bioburden Control Strategies and Validation exercises as needed. Ensure CCS process is maintained through the support and oversight of floor operations, Manufacturing Campaign Reviews, Ongoing Process Verification (OPV) and Annual Product Reviews (APR).
* Carry out investigations, identify CAPA plans and present them to deviation board as applicable.
* Own change controls implementation, which is expected to be completed in an effective and timely manner.
* Maintain an effective collaboration with secondary loop personnel, TS/MS laboratory, other functions, and other Lilly manufacturing sites to identify best practices for replication.
* Ensure data integrity and verification procedures are followed. Provide technical support on cleaning processes for new product introduction.
Basic Requirements
* Bachelor's degree in scientific disciplines such as Molecular Biology or Microbiology with 3 to 5 years of experience in pharmaceutical manufacturing and/or in a CCS program is required.
* Master or PhD degree in scientific disciplines such as Molecular Biology or Microbiology with 1-3 years of experience in pharmaceutical manufacturing and/or in a CCS program.
* Candidate should demonstrate a strong scientific and technical knowledge in microbiology, and statistical data analysis, technical writing.
* Knowledge of cGMPs.
* Strong technical writing and presentation skills.
* Proficiency in process data analysis using statistical tools.
* Excellent interpersonal skills that foster engagement and teamwork in a cross-functional environment.
* Fully bilingual (English and Spanish).
* Team-oriented with strong collaboration skills.
* Ability to influence and exercise sound judgment.
* Demonstrated leadership capabilities.
* Excellent oral and written communication skills.
* Ability to manage multiple assignments in a dynamic environment.
* Availability to support 24/7 operations.
* Relevant industrial experience in Chemical Engineering, development or Quality in Pharmaceutical or Protein Manufacturing Operations is desirable.
Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$52,500 - $154,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyScientist (EMPQ)
Chemist job in Juncos, PR
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Summary of Role:
The consultant will develop and execute Environmental Qualification, Airflow Visualization Study (AVS) and Aseptic Process Simulation (APS) deliverables for operational readiness projects.
Responsibilities:
Responsible for the Activities before Environmental monitoring performance qualification (EMPQ) execution
Responsible for the EMPQ execution & post approval
Responsible for the Air Visualization Studies
Responsible for the Aseptic Process Simulation Media Fill (MF)
Participate in project meetings, as applicable
Generate Validation Plan establishing lean strategies, as required.
Develop and execute EM PQ, AVS and APS protocols for applicable systems
Develop EM PQ, AVS and APS reports for applicable systems
Evaluate, coordinate, and execute the required efforts (resources, plant support, equipment, materials, etc.) to support projects deliverables.
Comply with projects schedule and escalate any roadblock or issues immediately including proposed mitigation plan.
Provide support during documentation transfer to DMS or Quality.
Shift: (1st, 2nd, and 3rd Shift)
Location: Juncos, PR
Education: Bachelor's degree in Engineering or a Scientific field.
Preferred Qualifications:
5+ years of experience in a regulated industry.
Experience with Environmental monitoring performance qualification (EMPQ) execution
Preferred experience with Aseptic Process Simulation Media Fill (MF)
Strong knowledge of cGMP/FDA regulations
Strong communication skills (oral and written)
Ability to organize and manage multiple tasks in a fast-paced environment
Attention to detail
Demonstrated problem solving and analytical skills
This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.
What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit **************************************
Full time Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc
Auto-ApplyLL01-251118 Quality Control Scientist III
Chemist job in Manat, 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:
Quality Control Scientist III
Qualifications:
Bachelor's Degree in Science.
Minimum of 8 years of experience in direct pharmaceutical quality control areas and regulatory operations.
Must be fully bilingual (English / Spanish) with excellent oral skills.
Must be proficient using MS Windows and Microsoft Office applications.
Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
Strong knowledge (according to related area).
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
Evaluate compendial changes from the different pharmacopeias.
Generate trend reports of investigations based on the company's procedures.
Evaluate global documents against site-specific procedures and update the site procedure accordingly.
Draft technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports, based on corporate policies, SOPs, compendial guidelines, ICH, DEA, and FDA regulatory guidance.
Generate required change requests for analytical documents and route documents for review and approval.
Conduct laboratory event/out-of-specification/out-of-trend investigations and close them on time.
Scientist (EMPQ)
Chemist job in Juncos, PR
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Summary of Role:
The consultant will develop and execute Environmental Qualification, Airflow Visualization Study (AVS) and Aseptic Process Simulation (APS) deliverables for operational readiness projects.
Responsibilities:
* Responsible for the Activities before Environmental monitoring performance qualification (EMPQ) execution
* Responsible for the EMPQ execution & post approval
* Responsible for the Air Visualization Studies
* Responsible for the Aseptic Process Simulation Media Fill (MF)
* Participate in project meetings, as applicable
* Generate Validation Plan establishing lean strategies, as required.
* Develop and execute EM PQ, AVS and APS protocols for applicable systems
* Develop EM PQ, AVS and APS reports for applicable systems
* Evaluate, coordinate, and execute the required efforts (resources, plant support, equipment, materials, etc.) to support projects deliverables.
* Comply with projects schedule and escalate any roadblock or issues immediately including proposed mitigation plan.
* Provide support during documentation transfer to DMS or Quality.
Shift: (1st, 2nd, and 3rd Shift)
Location: Juncos, PR
Education: Bachelor's degree in Engineering or a Scientific field.
Preferred Qualifications:
* 5+ years of experience in a regulated industry.
* Experience with Environmental monitoring performance qualification (EMPQ) execution
* Preferred experience with Aseptic Process Simulation Media Fill (MF)
* Strong knowledge of cGMP/FDA regulations
* Strong communication skills (oral and written)
* Ability to organize and manage multiple tasks in a fast-paced environment
* Attention to detail
* Demonstrated problem solving and analytical skills
This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.
What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit **************************************
Full time
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated Companies
Affiliated Companies: Echo Consulting Group Inc
Auto-ApplyQC Analyst
Chemist job in Manat, PR
Validation & Engineering Group (VEG) is a leading services supplier 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.
Job Description
Responsible for performing chemical and physical testing and analysis in accordance with prescribed methods, procedures and regulations. Performs a variety of duties related to the efficient and effective functioning of the laboratory.
Performs chemical and physical testing and analysis to raw materials, in-process product, validation samples, special samples, finished goods, and stabilities in accordance with prescribed methods, procedures and regulations.
Reports any deviation or suspect result immediately to the laboratory supervisor and collaborates to identify the root cause.
Accurately and timely captures and document data. Promptly enters data into respective system. Maintains detailed records in compliance with applicable procedures.
Reviews laboratory data for validity and accuracy. Reports any non conformances.
Executes validation protocols and documents results.
Troubleshoots and maintains laboratory equipment and instruments.
Assists with Change Controls.
Maintains laboratory supplies and assures adequate inventory.
Qualifications
Bachelor Degree in Sciences, preferred in Chemistry or Biochemistry
Active license preferred,(based on professional experience for the job, Chemical Technology, Biology, Microbiology, and Medical Technology may be considered).
This position requires one year of relevant experience in laboratory.
Additional Information
Positions available for Puerto Rico.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.
PD Scientist
Chemist job in Juncos, PR
At Kelly Science, Engineering, Technology & Telecom (SETT), we're passionate about helping you find a job that works for you. How about this one? We're seeking a **Process Development Scientist** to work with one of our top global biopharmaceutical clients in the Juncos PR area. With us, it's all about finding the job that's just right.
**Requirements:**
+ Doctorate or master's degree and 2 years of Scientific experience or bachelor's degree and 4 years of Scientific experience.
+ Advanced scientific analysis, laboratory work skills, and troubleshooting skills.
+ Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
+ Strong technical writing skills, negotiation, and conflict resolution.
+ Computer literacy Windows environment: Word, Excel, PowerPoint.
+ Strong knowledge of cGMP.
+ Fully bilingual English/Spanish.
+ Administrative Shift.
**What happens next:**
Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry-even if this position doesn't work out, you're still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what's next in your career is what we're all about, so let's get to work. Apply to be a **PD Scientist** today!
**Kelly PR Offers!**
Exposure to a variety of career opportunities because of our expansive network of client companies
Career guides, information, and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Bi-weekly pay
Among other benefits!
**Apply Today!**
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (********************************************************************* for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Quality Control Scientist, Laboratory Chemist
Chemist job in Juncos, PR
Validation & Engineering Group (V&EG) is a leading services supplier 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.
Job Description
Under general direction, functions as the technical specialist for testing & development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. Functions: Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise. Resolve technical issues and troubleshoot for assays as necessary, Ensure lab compliance - which includes implementing procedures that enhance GMP, GLP and safety. Manage existing and/or develop and implement new programs, processes and methodologies, Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact. Approve lab investigations, Lead audit teams
May serve as subject matter expert to develop technical training. May perform routine work in a specific area of responsibility as necessary. Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.. May interact with regulatory agencies regarding area(s) of responsibility including written responses. May resolve issues with outside resources. Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.
Competencies/Skills: Understand, support and demonstrate values. Excellent communication skills, facilitation and presentation skills. Excellent technical writing skills. Strong computer operation skills including work processing, presentation, database and spreadsheet application skills, Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion. Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility. Knowledge of pharmaceutical processes, Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products. Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products
Extensive knowledge and application of GMPs/CFRs. Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines. Proficient at maintenance, troubleshooting and operation of equipment in area of expertise. Advanced scientific data analysis and interpretation skills. Advanced skills in solving complex problems. Advanced data trending and evaluation. Strong skill in working independently and to effectively interact with various levels. Ability to interact with regulatory agencies both orally and in writing. Initiate, coordinate and lead cross functional teams. Excellent skill in leading, motivating, influencing, and negotiating
Qualifications
Expertise in Technical Writing, must have written reports for investigations, method transfers/validations,
• Root Cause Analysis experience and CAPA identification and implementation
• Fully bilingual English/Spanish
• Meeting and conference calls facilitator, with multilevel audience (Upper level Management to analysts)
• Presentation skills
• Oriented to solve problems and troubleshoot, technical proficiency
• Simple statistical assessments
Doctorate degree in Sciences or Master's degree in Sciences & 3 years of directly related experience or Bachelor's degree in Sciences & 5 years of directly related experience
• BS in Chemistry or Biochemistry preferred
• Knowledge in TrackWise, CDOCS, Maximo
• Knowledge in PowerPoint, Excel, Word, One Note
Additional Information
Positions available for Puerto Rico.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.
Scientist TSMS -CCS/Cleaning
Chemist job in Carolina, PR
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Job requisition Scientist-TSMS CCS
Responsibilities:
* The Scientist-TSMS CCS will provide direct technical support to the cleaning validation program of the fermentation and protein purification manufacturing processes. The candidate will own the Cleaning Control Strategy, including the cleaning parameters, and the historic and potential failure modes associated countermeasures.
* The candidate will be responsible for the definition and implementation of the routine process monitoring plan and ensure that process monitoring plan is aligned with the Cleaning Control Strategy and thus the process remains in control. The selected candidate will be primary responsible for proactively detecting any change in cleaning data variability and identifying/implementing actions as response to it. She/he will be responsible to drive the cleaning improvement agenda. Translate cleaning process requirements and educating Process Teams and operators; design, review, and deliver Process School(s) at the beginning of each campaign, as applicable.
* The selected candidate will be responsible for technical documentation of the cleaning program in official sources such as: Process Flow Diagrams (PFDs), Quality Risk Assessments, manufacturing instructions, SOP's and technical reports. Participates in the design and execution of Process, Cleaning, Bioburden Control Strategies and Validation exercises. Ensure cleaning process remains in a validated state via routine monitoring, Manufacturing Campaign Reviews, Ongoing Process Verification (OPV) and Annual Product Reviews (APR).
* He/she will be responsible to carry out investigations, identify CAPA plans and present them to deviation board. The candidate will own change controls implementation, which are expected to be completed in an effective and timely manner. Maintain an effective collaboration with secondary loop personnel, TS/MS laboratory, other functions, and other Lilly manufacturing sites to identify best practices for replication. Ensure data integrity and verification procedures are followed. Provide technical support on cleaning processes for new product introduction.
Basic Qualifications
* Bachelor's or master's degree in Chemical Engineering ( preferred ), Industrial Engineering or Biochemistry ( Molecular Biology).
* 2-5 years of experience in a regulated pharmaceutical manufacturing and/or in a cleaning validation program is required. Demonstrated strong scientific and technical knowledge in microbiology, engineering, fermentation, statistical data analysis, technical writing and project management is desirable.
* Knowledge of cGMP's
* Strong technical writing and presentation skills
* Strong process data analysis using statistical tools
* Excellent interpersonal skills that promote engagement and teamwork within cross-functional environment
* Fully bilingual (English and Spanish)
* Teamwork oriented
* Ability to influence; exercise sound judgment
* Demonstrated leadership skills
* Excellent communication skills, both oral and written.
* Work with multiple assignments at a time and within an environment with distractions.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$52,500 - $154,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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