At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!
Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.
POSITION SUMMARY .
The Senior Validation Specialist will conduct qualification and validation studies for manufacturing processes, equipment, and utilities
• Provides technical assistance, as needed, for manufacturing and engineering troubleshooting
• Responsible for the coordination of supportive validation activities (such as laboratory testing, calibration, scale-up and engineering studies) and assurance that the necessary project documentation is complete, accurate and in compliance with cGMP regulations.
• Evaluate qualification and validation projects to establish technically and scientifically sound protocols and test plans.
• Execute protocols by carrying out the preapproved testing in the operations and laboratory areas.
• Collect and analyze all data, write final report and obtain approvals.
• Review technical documentation (batch records, SOPs, calibration records, preventive maintenance
work orders, protocols, reports) for continuity and accuracy.
• Perform gap assessments and remediation as required on legacy qualification and validation packages.
• Write SOPs and protocols to support departmental programs and projects.
• Evaluate, maintain and operate validation instrumentation as required in order to support assigned projects (examples: Kaye Validator 2000, dew point monitor).
• Coordinate successful execution of projects by working effectively with cross-functional groups.
• May be involved in investigation and root cause analysis for incidents reported on validated systems
• Other duties as assigned
• Bachelor’s degree in Engineering, or in a scientific discipline, or equivalent experience
• Ability to work harmoniously and effectively with others in a fast-paced environment.
• Ability to effectively communicate technical information in a clear, concise manner within a GMP-regulated environment
• Flexibility to work off-hours and weekends as required to support manufacturing plant projects
• Ability to effectively manage multiple projects simultaneously (4-6 typical)
• May be required to move about the facility
• May be required to wear personal protective equipment
• May be required to remain sedentary for periods of time
• Bachelor’s degree in Engineering, or in a scientific discipline