161 Senior Validation Engineer Jobs in Jersey, NJ
Katalyst Healthcares & Life Sciences is Hiring a Senior Validation Engineer Near Jersey, NJ
- Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects.
- Prepare and execute commissioning / validation lifecycle documents.
- Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade.
- Write summary reports for validation and qualification protocols.
- Support project milestones, priorities and deadlines.
- Write operating procedures for technical equipment and practices and procedures.
- Perform system and process risk assessments and analyses.
- Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management.
- Develop project specific validation plans and strategy.
- Able to manage and execute multiple projects to meet client's priorities.
- Provide a practical approach to problem solving.
- Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers.
- Bachelor's degree in a related life sciences or requisite industry training and experience.
- 5 10 years GMP experience.
- Ability to converse about scientific matters.
- Ability to work independently or in collaboration with others.
- In depth understanding and application of validation principles, concepts, practices and standards.
- Considered a Subject Matter Expert (SME) in one area of validation.
- Proficient in current Good Manufacturing Practices and other applicable regulations.
- Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration.
- User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report.
- Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards.
- Excellent written communication skills with emphasis on technical writing.
- Proficient in Microsoft Word, Excel, Power Point and Project.
Job Summary
Contractor
$123k-143k (estimate)
07/03/2024
07/28/2024
katalysthls.com
South Plainfield, NJ
<25
Related Companies
The job skills required for Senior Validation Engineer include Planning, Risk Assessment, Written Communication, Collaboration, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Validation Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Validation Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Validation Engineer positions, which can be used as a reference in future career path planning. As a Senior Validation Engineer, it can be promoted into senior positions as a Validation Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Validation Engineer. You can explore the career advancement for a Senior Validation Engineer below and select your interested title to get hiring information.
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