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
20 jobs near Columbus, OH
ISPE Baseline Guides and GAMP 5 * Applicable domestic and international regulatory standards * Manage multiple high-priority projects simultaneously, balancing competing demands while consistently ...
New
Ensure compliance with applicable international regulations, standards, and industry requirements. * Support technical problem-solving and troubleshooting efforts across sterilization-related ...
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Ensure compliance with applicable international regulations, standards, and industry requirements. * Support technical problem-solving and troubleshooting efforts across sterilization-related ...
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 ...
New
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 ...
New
$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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$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 ...
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: 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
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 ...
$101K - $131K/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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$101K - $131K/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: 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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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.
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 ...
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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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
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.
New
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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.
New
PR · On-site
SUMMARY: Under limited supervision, execute advanced maintenance activities or operate assigned equipment, facility, utility, and HVAC Systems in accordance with established guidelines and operating ...
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PR · On-site
SUMMARY: Under limited supervision, execute advanced maintenance activities or operate assigned equipment, facility, utility, and HVAC Systems in accordance with established guidelines and operating ...
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
Summary: The Capital Engineering Department of a pharmaceutical manufacturing company is responsible for planning and executing capital projects that support manufacturing, packaging, laboratories ...
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Summary: The Capital Engineering Department of a pharmaceutical manufacturing company is responsible for planning and executing capital projects that support manufacturing, packaging, laboratories ...
Space Planning Coordinator
Juncos, PR · On-site
Summary: Serve as a strategic liaison between the Capital Projects department and the Facilities team, coordinating space planning, personnel movements, and material relocation to ensure operational ...
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Space Planning Coordinator
Juncos, PR · On-site
Summary: Serve as a strategic liaison between the Capital Projects department and the Facilities team, coordinating space planning, personnel movements, and material relocation to ensure operational ...
PR · On-site
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.
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PR · On-site
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.
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 ...
Quick apply
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 ...
Summary We are seeking a detail-oriented Purchasing Agent with experience in procurement, supplier coordination, and invoice discrepancy resolution within a fast-paced environment. The ideal ...
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Summary We are seeking a detail-oriented Purchasing Agent with experience in procurement, supplier coordination, and invoice discrepancy resolution within a fast-paced environment. The ideal ...
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
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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
$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 ...
Full-time, Contractor
Posted yesterday
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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.
- 3-5 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:Â August 2026
- Project term: 6-12 months with potential extensions
- Amount of openings: 4
- 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