Validation (CQV) Engineer 

Senior Validation (CQV) Engineer 
 1 year assignment
This particular assignment would be to support new plant commissioning and qualification activities for a new plant start up in Western Michigan!

Focus on Process Validation activities for autoclave, mixing tanks/pumps, powder mixing, fermenter skid, holding tanks, buffer tanks
2-10 years of experience

Requirements
•    You’ve earned your BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
•    You’ve gained 2-10 years relevant industry experience working in a cGMP environment., with experience with equipment, process and computer system qualification.
•    You’ve got working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals, and medical devices in your toolbox.
•    You’ve collected previous experience in writing and executing Validation protocols such as Installation, Operation and Performance Qualification documents.
•    Experience with enterprise systems.
Rate:  $42.00, so will probably be pretty junior!!

 Fishers, IN
New Contract Manufacturing facility needing ongoing CQV support
Mostly filling focused – vials/syringes/cartridges
Typical Project Accountabilities Include:
•    Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation.
•    Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client’s quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.
•    Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support.
•    Manage and work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.
•    Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope.
Requirements
•    A minimum of a bachelor’s degree in an Engineering or Scientific degree
Preferred:
•    3+ years’ experience in GMP regulated environment
•    Preferable experience includes process equipment, protocol execution, and summary report writing
•    Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls)
•    Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
•    Intermediate to Expert (Senior and Lead) knowledge of FDA regulations, ISPE guidelines and ISO standards including Good Documentation Practice (GDP) in pharmaceutical environment
•    ASTM-E2500
•    Rate:  48.00

Senior Validation (CQV) Engineer 
 1 year assignment
This particular assignment would be to support new plant commissioning and qualification activities for a new plant start up in Western Michigan!

Focus on Process Validation activities for autoclave, mixing tanks/pumps, powder mixing, fermenter skid, holding tanks, buffer tanks
2-10 years of experience

Requirements
•    You’ve earned your BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
•    You’ve gained 2-10 years relevant industry experience working in a cGMP environment., with experience with equipment, process and computer system qualification.
•    You’ve got working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals, and medical devices in your toolbox.
•    You’ve collected previous experience in writing and executing Validation protocols such as Installation, Operation and Performance Qualification documents.
•    Experience with enterprise systems.
Rate:  $42.00, so will probably be pretty junior!!

 Fishers, IN
New Contract Manufacturing facility needing ongoing CQV support
Mostly filling focused – vials/syringes/cartridges
Typical Project Accountabilities Include:
•    Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation.
•    Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client’s quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.
•    Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support.
•    Manage and work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.
•    Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope.
Requirements
•    A minimum of a bachelor’s degree in an Engineering or Scientific degree
Preferred:
•    3+ years’ experience in GMP regulated environment
•    Preferable experience includes process equipment, protocol execution, and summary report writing
•    Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls)
•    Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
•    Intermediate to Expert (Senior and Lead) knowledge of FDA regulations, ISPE guidelines and ISO standards including Good Documentation Practice (GDP) in pharmaceutical environment
•    ASTM-E2500
•    Rate:  48.00