PR · On-site
ISPE Baseline Guides and GAMP 5 * Applicable domestic and international regulatory standards * Manage multiple high-priority projects simultaneously, balancing competing demands while consistently ...
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CIS International
24 jobs near Columbus, OH
PR · On-site
ISPE Baseline Guides and GAMP 5 * Applicable domestic and international regulatory standards * Manage multiple high-priority projects simultaneously, balancing competing demands while consistently ...
PR · On-site
ISPE Baseline Guides and GAMP 5 * Applicable domestic and international regulatory standards * Manage multiple high-priority projects simultaneously, balancing competing demands while consistently ...
Quick apply
PR · On-site
ISPE Baseline Guides and GAMP 5 * Applicable domestic and international regulatory standards * Manage multiple high-priority projects simultaneously, balancing competing demands while consistently ...
PR · On-site
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
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PR · On-site
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
SUMMARY: The Data Scientist will lead projects and collaborate with business partners including commercial insights teams, manufacturing, supply chain, engineering, data teams, external vendor ...
New
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SUMMARY: The Data Scientist will lead projects and collaborate with business partners including commercial insights teams, manufacturing, supply chain, engineering, data teams, external vendor ...
New
Engineering Program Manager- MES
Ponce, PR · On-site
$110 - $150/hr
Summary: The Engineering Program Manager - Manufacturing Execution System (MES) will lead the planning, governance, and execution of MES initiatives supporting manufacturing operations at the Ponce ...
New
Engineering Program Manager- MES
Ponce, PR · On-site
$110 - $150/hr
Summary: The Engineering Program Manager - Manufacturing Execution System (MES) will lead the planning, governance, and execution of MES initiatives supporting manufacturing operations at the Ponce ...
New
SUMMARY: Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital ...
New
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SUMMARY: Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital ...
New
PR · On-site
SUMMARY: To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
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PR · On-site
SUMMARY: To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
Summary: Responsible for coordinating projects, inventory activities, and operational initiatives to support business continuity and manufacturing operations. The Project Coordinator collaborates ...
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Summary: Responsible for coordinating projects, inventory activities, and operational initiatives to support business continuity and manufacturing operations. The Project Coordinator collaborates ...
PR · On-site
SUMMARY: Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital ...
New
Quick apply
PR · On-site
SUMMARY: Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital ...
New
PR · On-site
SUMMARY: To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
Quick apply
PR · On-site
SUMMARY: To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
Sr. Quality Application Specialist (Science)/ Sr. Quality Engineer (Engineer)
Juncos, PR · On-site
$86K - $116K/yr
Key Requirements: * Bachelor's degree in Engineering or Science. * Knowledge and experience with IT systems and integrations with manufacturing equipment. * Minimum of 4 years of experience in ...
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Sr. Quality Application Specialist (Science)/ Sr. Quality Engineer (Engineer)
Juncos, PR · On-site
$86K - $116K/yr
Key Requirements: * Bachelor's degree in Engineering or Science. * Knowledge and experience with IT systems and integrations with manufacturing equipment. * Minimum of 4 years of experience in ...
PR · On-site
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
Quick apply
PR · On-site
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
PR · On-site
$89K - $122K/yr
SUMMARY: To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or ...
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PR · On-site
$89K - $122K/yr
SUMMARY: To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or ...
Sr. Engineer- 35409 (Reliability Engineer)
Juncos, PR · On-site
$85 - $120/hr
Sr. Engineer- 35409 (Reliability Engineer) SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the ...
New
Sr. Engineer- 35409 (Reliability Engineer)
Juncos, PR · On-site
$85 - $120/hr
Sr. Engineer- 35409 (Reliability Engineer) SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the ...
New
Product Development Engineer
Juncos, PR · On-site
Summary: The Product Development Engineer supports the design, development, and continuous improvement of medical device products by implementing engineering changes, maintaining design documentation ...
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Product Development Engineer
Juncos, PR · On-site
Summary: The Product Development Engineer supports the design, development, and continuous improvement of medical device products by implementing engineering changes, maintaining design documentation ...
SUMMARY Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision. FUNCTIONS * Review and approve product MPs.
New
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SUMMARY Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision. FUNCTIONS * Review and approve product MPs.
New
Field Technician - Vegetation & Soil Surveys (PR & USVI)
San Juan, PR · On-site
$20.74/hr
Summary: This project involves the characterization of soils and vegetation at selected locations in Puerto Rico and the United States Virgin Islands for the United States Department of Agriculture ...
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Field Technician - Vegetation & Soil Surveys (PR & USVI)
San Juan, PR · On-site
$20.74/hr
Summary: This project involves the characterization of soils and vegetation at selected locations in Puerto Rico and the United States Virgin Islands for the United States Department of Agriculture ...
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
New
Quick apply
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
New
PR · On-site
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
Quick apply
PR · On-site
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
PR · On-site
Summary: Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico.
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PR · On-site
Summary: Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico.
Full-time, Contractor
Posted 15 days ago
Job description
Summary:
Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico.
Responsibilities:
Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico.
Responsibilities:
- Provide technical leadership for commissioning, qualification, and computer system validation activities, including:
- Leading and executing end-to-end qualification and lifecycle management of facilities, utilities, manufacturing equipment, process systems, and computerized systems.
- Planning, coordinating, and delivering qualification and validation project milestones within scope, timeline, and budget constraints.
- Developing, reviewing, approving, and executing validation lifecycle documentation, including Validation Master Plans, User Requirements Specifications (URS), Functional and Design Specifications, Risk Assessments, Commissioning Plans, IQ/OQ/PQ protocols, and summary reports.
- Directing protocol execution activities, including data collection, field sampling, data trending, statistical analysis, deviation assessment, root cause investigations, and implementation of corrective actions.
- Monitoring, tracking, and communicating validation project status, risks, and deliverables to project teams and leadership.
- Develop and scientifically justify validation strategies, acceptance criteria, sampling plans, and protocol designs based on risk management principles, process understanding, and industry best practices.
- Evaluate and document the impact of change controls on qualified systems, validated processes, facilities, utilities, and computerized systems, ensuring compliance with site and regulatory requirements.
- Lead and support investigations, deviations, and CAPAs, providing technical expertise to resolve complex quality, validation, and manufacturing issues.
- Develop, implement, and continuously improve validation procedures, standards, policies, and lifecycle management practices aligned with regulatory expectations and industry trends.
- Maintain compliance with current global regulatory requirements and industry guidance, including but not limited to:
- 21 CFR Parts 210, 211, and 11
- EU GMP Annex 11 and Annex 15
- ICH Q8, Q9, and Q10
- ISPE Baseline Guides and GAMP 5
- Applicable domestic and international regulatory standards
- Manage multiple high-priority projects simultaneously, balancing competing demands while consistently meeting aggressive timelines and business objectives.
- Perform other duties and special projects as assigned.
- Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- 7-10 years’ experience in pharmaceutical or regulated manufacturing environment; ideally, the candidate will have previous Oral Solid Dose (OSD) manufacturing experience.
- Professional services agreement (independent contractor)
- Full time job
- Full on site job in Vega Baja, Puerto Rico
- Languages: Spanish and English
- Type of industry: Pharmaceutical
- Expected hiring date: August 2026
- Project term: 6-12 months with potential extensions
- Amount of openings: 3
- Administrative shift, wiling to support non-admin hours
About CIS International
Sourced by ZipRecruiter
Company size
11 - 50 Employees
Headquarters location
Gardena, CA, US
Year founded
1991