Senior Validation Engineer

Piper Companies; Durham (NC); Sur place; USD 96 000 - 110 000; Plein temps

Résumé du poste

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing client in a GMP environment. This role focuses on validation activities across fill/finish operations, equipment qualification, process validation, and compliance initiatives.

Based onsite in Clayton, NC, you will drive validation strategy, execute IQ/OQ/PQ protocols, lead investigations and deviations, and oversee change control, documentation, and continuous improvement for critical

Qualifications

• Bachelor's degree in engineering, computer science, or a related technical field; equivalent experience considered.
• Master's degree preferred.

Responsabilités

• Provide validation and technical support through IQ/OQ/PQ protocols.
• Own Change Requests related to validation activities and project deliverables.
• Author and review Validation Plans, PQMPs, protocols, reports, and validation documentation.
• Execute validation activities for direct-impact systems, equipment, and processes.
• Perform compliance reviews and technical approvals of protocols, reports, and validation data.
• Lead validation investigations, deviations, and non-conformances using root cause analysis.
• Ensure validation activities comply with local, corporate, and regulatory requirements.
• Create and revise validation procedures, CILs, specifications, and SOPs.
• Support FAT, SAT, commissioning, qualification, and startup activities.
• Identify process improvements and support continuous improvement initiatives.
• Provide contractor oversight, project coordination, and budget support.
• Lead validation activities and serve as SME for new systems and equipment implementations.

Connaissances

Leadership

Cross-functional collaboration

Root cause analysis

Technical writing

Formation

Bachelor's degree in Engineering/CS or related

Master's degree preferred

Description du poste

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing client. This role will focus on validation activities within a regulated GMP environment, supporting fill/finish operations, equipment qualification, process validation, and compliance initiatives. The Senior Validation Engineer will serve as a technical leader, driving validation strategy, execution, investigations, and change management efforts across critical manufacturing systems and processes.

This is a long-term W2 contract opportunity requiring 5 days/week onsite in Clayton, NC. The position offers a highly visible role supporting complex pharmaceutical manufacturing projects with opportunities to lead validation efforts from commissioning through process qualification.

Responsibilities of the Senior Validation Engineer:

• Provide validation and technical support through the preparation, execution, data analysis, and reporting of IQ/OQ/PQ (IV/OV/PV) protocols.
• Own Change Requests (CRs) related to validation activities and project deliverables.
• Author and review Validation Plans (VPLs), Project Quality Master Plans (PQMPs), protocols, reports, and associated validation documentation.
• Execute validation activities for direct-impact systems, equipment, and processes while ensuring project timelines are met.
• Perform compliance reviews and technical approvals of protocols, reports, and validation data.
• Lead validation investigations, deviations, and non-conformances using root cause analysis methodologies.
• Ensure validation activities comply with local, corporate, and regulatory requirements.
• Create and revise validation procedures, configuration item lists (CILs), specifications, and SOPs as needed.
• Support FAT, SAT, commissioning, qualification, and startup activities for equipment, automation systems, and manufacturing processes.
• Identify process improvements and support continuous improvement initiatives.
• Provide contractor oversight, project coordination, and budget support as required.
• Lead validation activities and serve as a subject matter expert for new systems and equipment implementations.

Qualifications of the Senior Validation Engineer:

• Bachelor's degree in Engineering, Computer Science, or a related technical discipline; equivalent experience will be considered.
• Master's degree preferred.
• 7+ years of validation, quality, or related experience within the pharmaceutical or medical device industry.
• Strong knowledge of GMP manufacturing environments and validation lifecycle activities.
• Experience with regulatory and industry standards including 21 CFR Part 11, GAMP5, ISO standards, FDA regulations, and ICH guidance.
• Proven experience leading investigations and applying root cause analysis techniques to resolve complex issues.
• Ability to author and review technical documentation, protocols, reports, and procedures.
• Demonstrated project leadership, communication, and cross-functional collaboration skills.
• Experience managing multiple priorities and delivering projects within established timelines.
• Strong understanding of change control processes and validation compliance requirements.
• Pharmaceutical manufacturing and fill/finish experience preferred.

Compensation & Benefits for the Senior Validation Engineer:

• Competitive pay: $70-$80/hour, flexibility based on years of experience
• Full benefits package including medical, dental, vision, and 401(k)
• Long-term contract opportunity with strong project stability
• Opportunity to lead high-impact validation projects within a state-of-the-art pharmaceutical manufacturing environment

Key Words:

Senior Validation Engineer, Validation Engineer, Pharmaceutical Validation, Fill Finish, Fill/Finish Manufacturing, IQ/OQ/PQ, Equipment Qualification, Process Validation, GMP, cGMP, FDA Compliance, 21 CFR Part 11, GAMP5, Commissioning, FAT, SAT, Change Control, Root Cause Analysis, Pharmaceutical Manufacturing, Quality Systems, Validation Lifecycle

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