Validation Engineer 1 of 1
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Job Location:
Norwood, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
he Role:Client is seeking a Senior Validation Engineer to support digital initiatives within the Bioanalytical and Molecular Assays department of CASL. This role will report directly to the Senior Manager of Operations and will be responsible for delivery of efficiencies to the Watson LIMS database along with establishment of robust data integrity solutions for metabolomic and genomic position is based in Norwood MA What Youll DoPartner with Operations team to support Data Integrity Risk Assessment (DIRA) initiative which will summarize potential risks and identify gaps in validated data-generating toward achievement of a seamless sample-receipt-to-data-delivery model by integrating shipment manifests and EDC with Watson LIMS and by leveraging custom reporting features of Watson metabolomic capabilities for LC-MS team by: Authoring Risk Assessment and partial User Test Cases for the high-resolution Orbitrap NGS (exosome-profiling) for molecular team by: Authoring Risk Assessment and partial User Test Cases for the Illumina NextSeq2000 BMA for data storage and movement solutions within AWS cloud environment to achieve data integrity for large metabolomic and genomic datasets. Heres What Youll Need (Basic Qualifications)Masters degree in engineering or related field or relevant experience; a combination of education and experience may be considered.5 - 8 years of experience working in a regulated (GLP/GCLP/GMP) Pharmaceutical/Biotechnology understanding of Computer Systems Validations and instrument lifecycle Matter Expert in Watson of the principles surrounding data integrity and digital compliance. Proficiency in Kneat Veeva and with Change Control Continuous Improvement and What Youll Bring to the Table (Preferred Qualifications)Strong communication skills (verbal and written).Demonstrated ability to work independently and collaboratively on cross-functional teams.A desire to make an impact as part of a high-growth transformational company that is Bold Relentless Curious and Collaborative.
Required Skills :
Basic Qualification :
Additional Skills :
This is a high PRIORITY requisition. This is a PROACTIVE requisition
Background Check : No
Drug Screen : No
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
