Job Description

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 #J-18808-Ljbffr

Job Tags

Similar Jobs