Two River Consulting Partners
0013V Senior CSV Analytical Instrument Engineer/Senior Validation Engineer Consu
Two River Consulting Partners, Summit, New Jersey, us, 07902
Looking for a strong resource with a diverse skillset focused around Analytical Instruments accompanied by a thorough understanding of CSV principles.
Knowledge and demonstrated experience of Computerized System and Analytical Equipment Validation
Running test scripts and documenting results
Experience working with IT and troubleshooting
Experience with requirements gathering and root cause analysis activities
Adherence with project schedule for all assigned activities
Maintaining clear, detailed, and compliant qualification and validation records
Understanding of system design and/or configuration activities
General understanding of capital equipment implementation and process knowledge.
Understanding with demonstrated experience drafting and executing validation documents, such as, Val Plans, URS, IQ/OQ/PQ protocols, RTM, VSR, Deviation Management, Change Management and Project Management
Understanding of system integrations, including but not limited to understanding of how integrations are designed / constructed, data flow from source systems to target systems, typical testing approach for system integrations
Designing and executing engineering studies for critical process parameter definition and verification prior to validation
Conducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes.
REQUIREMENTS
Bachelor’s Degree or equivalent required
4 to 6 year of relevant role specific experience
Proficiency using PC and Microsoft Office tools
Ability to work as part of a team
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
Experience in pharmaceutical cGxP setting with the ability to generate CSV/CQV deliverables
Knowledge of 21CFR Part 11 Regulation
Ability to work as part of a team
Direct experience and understanding of complex automated lab and manufacturing systems
LOCATION On-site in Summit, NJ
EMPLOYMENT C2C or W2 Contractor
#J-18808-Ljbffr
Knowledge and demonstrated experience of Computerized System and Analytical Equipment Validation
Running test scripts and documenting results
Experience working with IT and troubleshooting
Experience with requirements gathering and root cause analysis activities
Adherence with project schedule for all assigned activities
Maintaining clear, detailed, and compliant qualification and validation records
Understanding of system design and/or configuration activities
General understanding of capital equipment implementation and process knowledge.
Understanding with demonstrated experience drafting and executing validation documents, such as, Val Plans, URS, IQ/OQ/PQ protocols, RTM, VSR, Deviation Management, Change Management and Project Management
Understanding of system integrations, including but not limited to understanding of how integrations are designed / constructed, data flow from source systems to target systems, typical testing approach for system integrations
Designing and executing engineering studies for critical process parameter definition and verification prior to validation
Conducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes.
REQUIREMENTS
Bachelor’s Degree or equivalent required
4 to 6 year of relevant role specific experience
Proficiency using PC and Microsoft Office tools
Ability to work as part of a team
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
Experience in pharmaceutical cGxP setting with the ability to generate CSV/CQV deliverables
Knowledge of 21CFR Part 11 Regulation
Ability to work as part of a team
Direct experience and understanding of complex automated lab and manufacturing systems
LOCATION On-site in Summit, NJ
EMPLOYMENT C2C or W2 Contractor
#J-18808-Ljbffr