Sr. Validation Engineer
Juncos, PR · On-site
Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams. * Interface with system owners and technical authorities. * Provide technical guidance and ...
Sr. Validation Engineer
Juncos, PR · On-site
Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams. * Interface with system owners and technical authorities. * Provide technical guidance and ...
PR · On-site
Its services include Engineering, Project Management, and Validation. MMR Consulting has offices in ... This role is for Sr. CQV Engineer will require to work on the validation of upstream and downstream ...
PR · On-site
Its services include Engineering, Project Management, and Validation. MMR Consulting has offices in ... This role is for Sr. CQV Engineer will require to work on the validation of upstream and downstream ...
PR · On-site
Its services include Engineering, Project Management, and Validation. MMRConsulting hasofficesinCanada,USA,andAustralia. This is an outstanding opportunity to join our growing team, where the ...
Quick apply
PR · On-site
Its services include Engineering, Project Management, and Validation. MMRConsulting hasofficesinCanada,USA,andAustralia. This is an outstanding opportunity to join our growing team, where the ...
PR · On-site
Its services include Engineering, Project Management, and Validation. MMRConsulting hasofficesinCanada,USA,andAustralia. This is an outstanding opportunity to join our growing team, where the ...
PR · On-site
Its services include Engineering, Project Management, and Validation. MMRConsulting hasofficesinCanada,USA,andAustralia. This is an outstanding opportunity to join our growing team, where the ...
PR · On-site
$88K - $121K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$88K - $121K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$105K - $144K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$105K - $144K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$71K - $98K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$71K - $98K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$91K - $125K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$91K - $125K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$91K - $125K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$91K - $125K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$90K - $124K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$90K - $124K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$91K - $126K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$91K - $126K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$70K - $96K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$70K - $96K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
$91K - $126K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
$91K - $126K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
$91K - $125K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
$91K - $125K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$105K - $145K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$105K - $145K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$102K - $140K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$102K - $140K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Sr Engineer
Punta Santiago, PR · On-site
$103K - $142K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Sr Engineer
Punta Santiago, PR · On-site
$103K - $142K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$91K - $125K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$91K - $125K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$91K - $126K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$91K - $126K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
PR · On-site
$101K - $139K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Quick apply
PR · On-site
$101K - $139K/yr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...
Senior Validation Engineer information
What are the key skills and qualifications needed to thrive as a Senior Validation Engineer, and why are they important?
To thrive as a Senior Validation Engineer, you need a solid background in engineering, quality assurance, and regulatory compliance, typically supported by a relevant degree and experience in validation within regulated industries. Familiarity with validation protocols (IQ, OQ, PQ), statistical analysis tools, and systems like FDA 21 CFR Part 11 is crucial. Strong problem-solving, attention to detail, and effective communication skills help ensure successful project outcomes and cross-functional collaboration. These skills and qualifications are essential to maintain product quality, meet regulatory standards, and drive continuous improvement.
What does a Senior Validation Engineer do?
A Senior Validation Engineer is responsible for ensuring that products, systems, or processes meet regulatory standards and function as intended. They develop and execute validation protocols, analyze test data, and document results to confirm compliance with industry and company standards. Senior Validation Engineers often lead validation projects, collaborate with cross-functional teams, and mentor junior staff. Their work is critical in industries like pharmaceuticals, biotechnology, and manufacturing, where product safety and efficacy are essential.
What are some typical challenges faced by Senior Validation Engineers when leading validation projects?
Senior Validation Engineers often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and coordinating cross-functional teams. Balancing the needs of production, quality assurance, and regulatory affairs requires strong communication and project management skills. Additionally, troubleshooting unexpected validation failures and documenting results thoroughly are key aspects that demand both technical expertise and attention to detail.
What is the difference between Senior Validation Engineer vs Validation Specialist?
| Aspect | Senior Validation Engineer | Validation Specialist |
|---|---|---|
| Credentials | Bachelor's or Master's in Engineering, Life Sciences, or related fields; often with certifications like GxP or CSV | Similar educational background; certifications like GxP or CSV are common |
| Work Environment | Designs and oversees validation protocols in manufacturing, biotech, or pharmaceutical settings | Executes validation tasks, tests, and documentation in similar environments |
| Employer & Industry | Pharmaceutical, biotech, medical device companies | Same industries, often working under validation teams |
| Search & Comparison | Often compared for experience level and responsibilities | Commonly searched together for validation roles |
The main difference is that a Senior Validation Engineer typically leads validation projects, designs protocols, and oversees validation activities, while a Validation Specialist focuses on executing validation tests and documentation. Both roles require similar credentials and work in comparable environments, but the Senior Validation Engineer has more responsibility for planning and oversight.
What are the most commonly searched types of Validation Engineer jobs in Puerto Rico? The most popular types of Validation Engineer jobs in Puerto Rico are:
What are popular job titles related to Senior Validation Engineer jobs in Puerto Rico? For Senior Validation Engineer jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Senior Validation Engineer jobs in Puerto Rico look for? The top searched job categories for Senior Validation Engineer jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Senior Validation Engineer jobs? Cities in Puerto Rico with the most Senior Validation Engineer job openings:
What are popular job titles related to Senior Validation Engineer jobs in PR? For Senior Validation Engineer jobs in PR, the most frequently searched job titles are:
Contractor
Posted 12 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?