Sr. Validation Engineer
Juncos, PR · On-site
Validation and Packaging Equipment AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job ... Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain ...
FITS
45 Fits Validation Engineer Jobs Hiring Near You
Sr. Validation Engineer
Juncos, PR · On-site
Validation and Packaging Equipment AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job ... Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain ...
Process Validation Engineer
Dorado, PR · On-site
Bachelor's in Engineering with five (5) years of experience in Process Validation activities within ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Generate technical justification to ...
Process Validation Engineer
Dorado, PR · On-site
Bachelor's in Engineering with five (5) years of experience in Process Validation activities within ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Generate technical justification to ...
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Design manufacturing processes ... Guide engineers regarding design concepts and specification requirements to best utilize equipment ...
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Design manufacturing processes ... Guide engineers regarding design concepts and specification requirements to best utilize equipment ...
Validation Specialist
Dorado, PR · On-site
Bachelor's in Engineering with five (5) years of experience in Validation activities within the ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Utilize automated tools to extract and ...
Validation Specialist
Dorado, PR · On-site
Bachelor's in Engineering with five (5) years of experience in Validation activities within the ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Utilize automated tools to extract and ...
Validation Specialist
Dorado, PR · On-site
Quality Engineering or Manufacturing Engineering * Validation lifecycle and documentation ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Utilize automated tools to extract and ...
Validation Specialist
Dorado, PR · On-site
Quality Engineering or Manufacturing Engineering * Validation lifecycle and documentation ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Utilize automated tools to extract and ...
Develop validation engineering policies and procedures that affect multiple organizational units ... We're FITS! Are you the next piece?
Develop validation engineering policies and procedures that affect multiple organizational units ... We're FITS! Are you the next piece?
Project Manager - Validation
Juncos, PR · On-site
Bachelor's / Master's degree in Engineering, Microbiology, Biotechnology, or a science-related ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Lead and administer the Validation ...
Project Manager - Validation
Juncos, PR · On-site
Bachelor's / Master's degree in Engineering, Microbiology, Biotechnology, or a science-related ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Lead and administer the Validation ...
PR · On-site
$60K - $78K/yr
Experience: * Quality assurance focused on reviewing validation cycle documentation, quality ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Quality processes, including change ...
Associate Engineer
Arecibo, PR · On-site
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Generate and execute validation ... We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services ...
Associate Engineer
Arecibo, PR · On-site
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Generate and execute validation ... We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services ...
Manufacturing Engineer I - 158
Villalba, PR · On-site
$70K - $91K/yr
Validation of manufacturing processes and equipment * CSV Equipment Validation. * Cross-functional ... Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Manufacturing Engineer I - 158
Villalba, PR · On-site
$70K - $91K/yr
Validation of manufacturing processes and equipment * CSV Equipment Validation. * Cross-functional ... Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Project Manager
Barceloneta, PR · On-site
Develop validation engineering policies and procedures. * Project Management and lead The ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Lead the development and execution of C ...
Project Manager
Barceloneta, PR · On-site
Develop validation engineering policies and procedures. * Project Management and lead The ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Lead the development and execution of C ...
Quality Engineer- 02
Caguas, PR · On-site
$70K - $90K/yr
Validation Knowledge. * Documentation, Compliance and applicable regulations. * Effectively ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Understands product quality plans ...
Quality Engineer- 02
Caguas, PR · On-site
$70K - $90K/yr
Validation Knowledge. * Documentation, Compliance and applicable regulations. * Effectively ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Understands product quality plans ...
Manufacturing Engineer
Ponce, PR · On-site
$71K - $91K/yr
Validations * Interpreting engineering drawings, GD&T, and process specifications The Personality ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Optimize machining parameters to ...
Manufacturing Engineer
Ponce, PR · On-site
$71K - $91K/yr
Validations * Interpreting engineering drawings, GD&T, and process specifications The Personality ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Optimize machining parameters to ...
Quality Engineer II- 154
Juncos, PR · On-site
$70K - $91K/yr
Reviewing and approving Validation test plans, reports, and deviations. * Perform statistical ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Develops, modifies, applies, and ...
Quality Engineer II- 154
Juncos, PR · On-site
$70K - $91K/yr
Reviewing and approving Validation test plans, reports, and deviations. * Perform statistical ... AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Develops, modifies, applies, and ...
Engineer
Juncos, PR · On-site
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Resource should be capable of resolving ... or validation departments. * Work under the direct supervision of project managers to complete ...
Engineer
Juncos, PR · On-site
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Resource should be capable of resolving ... or validation departments. * Work under the direct supervision of project managers to complete ...
Engineer- 02
Juncos, PR · On-site
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Provide solutions to a variety of ... validation departments in developing requirements and recommendations for process and/or system ...
Engineer- 02
Juncos, PR · On-site
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Provide solutions to a variety of ... validation departments in developing requirements and recommendations for process and/or system ...
Sr. Packaging Engineer- 01
Juncos, PR · On-site
... validation * Vision system (inspection system analysis) AS A PIECE OF FITS, YOU WILL: (The day-to ... Develop engineering policies and procedures that affect multiple organizational units. * Supervise ...
Sr. Packaging Engineer- 01
Juncos, PR · On-site
... validation * Vision system (inspection system analysis) AS A PIECE OF FITS, YOU WILL: (The day-to ... Develop engineering policies and procedures that affect multiple organizational units. * Supervise ...
PR · On-site
For Quality Engineering services in the Process Development area. WHAT MAKES YOU A FIT: The ... FITS, YOU WILL: (The day-to-day on the job) * Support process and/or equipment validation ...
Senior Manufacturing Engineer
Juncos, PR · On-site
$89K - $121K/yr
Computer Systems validations The Personality Part: * If you have excellent communication skills and ... We're FITS! Are you the next piece?
Senior Manufacturing Engineer
Juncos, PR · On-site
$89K - $121K/yr
Computer Systems validations The Personality Part: * If you have excellent communication skills and ... We're FITS! Are you the next piece?
Process Development Engineer
Dorado, PR · On-site
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Support IQ/OQ/PQ and process ... validation plans. * Design and develop in-process and receiving inspection systems for new ...
Process Development Engineer
Dorado, PR · On-site
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) * Support IQ/OQ/PQ and process ... validation plans. * Design and develop in-process and receiving inspection systems for new ...
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Contractor
Posted 11 days ago
Job description
For C&Q services in the Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the next piece?
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's Degree in Engineering with four (4) years of Assembly and Packaging Process experience.
- Bilingual (English & Spanish).
- Project Management skills.
- Shift: Administrative and according to business needs.00
- Experience in:
- C&Q Process
- Validation and Packaging Equipment
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
- Develop C&Q plans, schedules, and resource forecasting.
- Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.
- Ensure systems are installed and operate per design specifications.
- Coordinate with vendors and contractors during startup activities.
- Review and approve commissioning documentation and test results
- Author, review, and approve qualification protocols (IQ, OQ, PQ).
- Ensure traceability from User Requirements Specifications (URS) through testing.
- Execute or oversee protocol execution and ensure proper documentation of results
- Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards.
- Maintain document lifecycle within electronic systems.
- Support data integrity and ALCOA+ principles throughout qualification activities.
- Prepare and support validation summary reports.
- Lead and document risk assessments related to system qualification.
- Evaluate and manage change controls impacting validated systems.
- Assess impact of deviations and implement corrective and preventive actions (CAPA)
- Develop the characterization protocols.
- Execute the characterization activities.
- Develop and review the characterization reports.
- Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.
- Interface with system owners and technical authorities.
- Provide technical guidance and mentorship to junior engineers and project team members.
- Support project meetings, status reporting, and stakeholder communication.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the next piece?