Facilities and Engineering Support Specialist
hace 3 semanas
The Facilities and Engineering Support Specialist will be a key contributor to maintaining the integrity and compliance of manufacturing facilities. This role involves providing crucial support in various areas including documentation changes, pest control program management support, deviations and Corrective and Preventive Actions (CAPAs), and Change Controls.
Responsibilities:
1. Documentation Changes:
Facilitate and manage documentation changes related to facilities and engineering processes.
Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
Collaborate with relevant stakeholders to implement documentation changes efficiently.
2. Pest Control Program:
Provide support to the pest control program to maintain a pest-free environment within the facility.
Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
Support the documentation and records related to the pest control program.
3. Deviations and CAPAs:
Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs).
Work closely with the Quality team to initiate and implement effective Corrective and Preventive Actions (CAPAs).
Monitor and track the progress of Deviations and CAPAs, ensuring timely closure and compliance.
4. Change Controls:
Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
Maintain Change Control records and provide support during regulatory inspections.
Qualifications:
Bachelor's degree in Engineering, Life Sciences, or a related field.
Strong understanding of documentation control, pest control programs, deviations/CAPA management, and Change Controls.
Knowledge of regulatory requirements, including FDA and other relevant authorities.
Excellent organizational, communication, and problem-solving skills.
Detail-oriented with a focus on quality and compliance.
Additional Requirements:
Available to work extended hours, possibility of weekends and holidays.
Fully bilingual - English and Spanish
-
Facilities and Engineering Support Specialist
hace 2 días
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoAbout the RoleWe are seeking a highly skilled Facilities and Engineering Support Specialist to join our team at Validation & Engineering Group, Inc. This role will play a crucial part in maintaining the integrity and compliance of our manufacturing facilities.ResponsibilitiesDocumentation Management: Facilitate and manage documentation changes related to...
-
Facilities and Engineering Support Specialist
hace 2 semanas
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob Summary:Validation & Engineering Group, Inc. is seeking a highly skilled Facilities and Engineering Support Specialist to join our team. As a key contributor to maintaining the integrity and compliance of our manufacturing facilities, this role involves providing crucial support in various areas, including documentation changes, pest control program...
-
Technical Engineering Specialist
hace 2 semanas
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob Role: Technical Engineering SpecialistThe Validation & Engineering Group, Inc. is seeking a highly skilled Technical Engineering Specialist to provide technical support and optimization services to our maintenance team. As a Technical Engineering Specialist, you will be responsible for ensuring that all maintenance operations and activities are in...
-
Senior Technical Specialist
hace 2 semanas
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob Summary:We are seeking a highly skilled Technical Specialist to join our team at Validation & Engineering Group, Inc. The successful candidate will be responsible for evaluating and optimizing Preventive & Predictive maintenance Job Plans at HVAC/Process Chilled Water & Cooling Towers systems.Key Responsibilities:Evaluate and optimize Preventive &...
-
Senior Technical Specialist
hace 3 semanas
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob Summary:We are seeking a highly skilled Senior Technical Specialist - Engineering to join our team at Validation & Engineering Group, Inc. The successful candidate will be responsible for evaluating and optimizing Preventive & Predictive maintenance Job Plans at the HVAC/Process Chilled Water & Cooling Towers systems. Additionally, they will support...
-
Senior Technical Engineering Specialist
hace 2 días
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob Summary:We are seeking a skilled Senior Technical Engineering Specialist to join our team at Validation & Engineering Group, Inc. in Juncos, 077. The ideal candidate will have expertise in chilled water, cooling towers, and HVAC systems, as well as experience in laboratory, compliance, computer, engineering, project management, validation, and other...
-
Technical Engineering Specialist
hace 4 semanas
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob Summary:The Validation & Engineering Group, Inc. is seeking a highly skilled Technical Engineering Specialist to provide technical support on system/equipment optimization strategies, upgrades, replacements, and modifications. The ideal candidate will ensure that all maintenance team operations and activities are maintained in compliance with corporate...
-
Technical Engineering Specialist Leader
hace 2 días
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoCompany Overview:", Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries in Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other areas. We are committed to working under the highest ethics standards and seeking dedicated individuals to join our team.Estimated...
-
Quality Assurance Specialist
hace 3 semanas
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob Summary We are seeking a highly skilled Quality Assurance Specialist to join our team at Validation & Engineering Group, Inc. The ideal candidate will have experience in manufacturing process audit and batch record review, as well as knowledge of DAI process, PASx/MES application, MAXIMO, SAP, and LIMS. Key Responsibilities - Review and approve product...
-
Juncos, Puerto Rico Mentor Technical Group A tiempo completoMentor Technical Group, a world leader in life science engineering and technical solutions, offers an exciting opportunity for a Technical Support Specialist to join their team. This role is ideal for individuals passionate about ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.As a Technical Support...
-
Senior Technical Project Lead
hace 4 días
Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoAbout the RoleFlexible & Integrated Technical Services, LLC is seeking a highly skilled Senior Technical Project Lead to join our team. This role will be responsible for leading complex engineering projects in the maintenance and engineering area.Job SummaryWe are looking for an exceptional individual with a strong background in engineering and project...
-
Technical Leader
hace 4 días
Juncos, Puerto Rico Mentor Technical Group A tiempo completoJob DescriptionMentor Technical Group, a world leader in life science engineering and technical solutions, is seeking an experienced Technical Leader to join our team.About UsWe provide comprehensive portfolio of technical support and solutions for the FDA-regulated industry. Our offices are located in Caguas, Puerto Rico, and Boston, serving clients in six...
-
Senior Quality Assurance Specialist
hace 2 semanas
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoOverview:Validation & Engineering Group, Inc. is a leading services provider that offers solutions to various industries. We are seeking a skilled individual to join our team as a Specialist QA.Primary Responsibilities:Perform various duties and responsibilities in support of the Quality Assurance program under minimal supervision.Participate in the triage...
-
Senior Engineering Specialist
hace 4 semanas
Juncos, Puerto Rico Inteldot A tiempo completoInteldot, a leading life science company, is seeking a highly skilled Senior Engineering Specialist to join our team. This is a fantastic opportunity for a talented engineer to take on a leadership role and drive process optimization strategies across our operations, manufacturing, and capital projects.As a Senior Engineering Specialist, you will be...
-
Lead Engineering Specialist
hace 4 días
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob SummaryWe are seeking a highly skilled and experienced Senior Technical Engineer to join our team at Validation & Engineering Group, Inc. The ideal candidate will have a strong background in engineering principles and practices, with the ability to apply knowledge outside of their area of discipline expertise.About UsValidation & Engineering Group, Inc....
-
Instrumentation Specialist
hace 3 semanas
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob Title: Instrumentation SpecialistJob Summary: We are seeking a talented Instrumentation Specialist to join our team at Validation & Engineering Group, Inc. The ideal candidate will have a strong background in Instrument related studies and experience in direct pharmaceutical, medical device or biotechnology operations.Key Responsibilities:Maintain...
-
Quality Assurance Specialist
hace 2 días
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoAbout the RoleWe are seeking a talented Quality Assurance Specialist to join our team at Validation & Engineering Group, Inc. in Juncos, 077.As a Quality Assurance Specialist, you will be responsible for approving process validation protocols and reports, requesting quality on incident triage teams, and releasing sanitary utility systems, among other...
-
Senior Engineering Specialist
hace 1 semana
Juncos, Puerto Rico Mirus Consulting Group A tiempo completoMirus Consulting Group is a leading provider of computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States.Job Title: Senior Engineering SpecialistAbout Mirus Consulting GroupWe are a local company based in Humacao, Puerto Rico that provides...
-
Quality Assurance Specialist
hace 2 semanas
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob Summary:Validation & Engineering Group, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Validation & Engineering Group, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Approve process validation protocols and reports for Quality Control and...
-
Environmental Health and Safety Specialist
hace 4 días
Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completoJob SummaryWe are seeking a skilled Environmental Health and Safety (EH&S) specialist to join our team at Validation & Engineering Group, Inc.About the RoleThis EH&S specialist will be responsible for providing technical expertise in managing environmental health and safety programs. This includes designing, developing, and implementing EH&S duties with...