Automation Systems, Biotech and Pharmaceutical, Budgeting, Change Control, Change Management, Change Requests/Orders, Code of Federal Regulations, Commissioning, Compensation and Benefits, Computer Science, Continuous Improvement, Cross-Functional, Data Analysis, Drug Manufacturing, FDA Requirements, GMP (Good Manufacturing Practices), ICH Regulations, ISO (International Organization for Standardization), Industry Standards, Leadership, Manufacturing, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Equipment, Multitasking, Problem Solving Skills, Process Development, Process Improvement, Process Validation, Project Tracking, Project/Program Coordination, Regulations, Regulatory Compliance, Regulatory Requirements, Root Cause Analysis, Standard Operating Procedures (SOP), System Start-Up, Team Player, Technical Leadership, Technical Support, Technical Writing, VPLS (Virtual Private LAN Service), Validation Documentation, Validation Plan, Writing Skills
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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