Participate in system testing, dry runs, and user acceptance testing activities.
Author and maintain lifecycle validation documents, including
User Requirements Specifications (URS)
Functional Design Specifications (FDS)
Design Specifications (DS)
Risk Assessments
Impact Assessments
FMEAs
IQ/OQ/PQ Protocols
Validation Reports
Develop and improve validation programs to maintain compliance with current regulatory expectations and industry standards.
Support the specification, implementation, qualification, troubleshooting, and maintenance of systems, equipment, and processes.
Participate in deviation investigations, root cause analysis, and CAPA activities.
Author validation master plans and project validation strategies.
Support documentation and validation activities related to MES, data historians, manufacturing applications, and supporting infrastructure.
Provide technical support for investigations, change controls, action plans, and risk assessments.
Contribute to continuous improvement initiatives and special projects as assigned.
Ensure compliance with applicable quality, safety, environmental, and regulatory requirements.
Qualifications
Required
Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.
1+ years of validation experience within a regulated cGMP pharmaceutical, biotech, medical device, or life sciences environment.
Experience generating and executing IQ/OQ/PQ protocols.
Working knowledge of CSV requirements and FDA-regulated manufacturing environments.
Strong understanding of cGMP regulations and validation lifecycle documentation.
Strong technical writing, communication, and problem-solving skills.
Ability to work effectively in a cross-functional team environment.
Proficiency with Microsoft Office applications.
Preferred
Experience with MES/eBR systems.
Experience with manufacturing applications, data historians, and automation systems.
Knowledge of aseptic manufacturing, cleanroom operations, or sterilization processes.
Experience with risk assessments, FMEA methodologies, deviations, CAPAs, and change controls.
Project coordination or project management experience.
Core Competencies
Strong analytical and troubleshooting skills.
Ability to manage multiple priorities and deadlines.
Sound judgment and decision-making abilities.
Effective verbal and written communication skills.
Ability to work independently with minimal supervision.
Adaptability in a fast-paced, regulated environment.
