Onsite Senior Validation Architect - GMP Fill/Finish Leader

Zachary Piper Solutions; Georgia; On-site; USD 96,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Job summary

Piper Companies is seeking a Senior Validation Engineer to lead validation strategy and execution within a GMP pharmaceutical environment, focusing on fill/finish, equipment qualification, and process validation.

This long-term W2 contract role is onsite in Clayton, NC, offering opportunities to drive validation efforts from commissioning through PQ, authoring and approving critical documentation, and ensuring regulatory compliance across manufacturing systems.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related field; equivalent experience considered.
• 7+ years of validation, quality, or related experience in pharmaceutical/medical device industry.
• Strong knowledge of GMP manufacturing environments and validation lifecycle activities.
• Experience with regulatory standards: 21 CFR Part 11, GAMP5, ISO, FDA regulations, ICH guidance.
• Proven experience leading investigations using root cause analysis.
• Ability to author and review technical documentation, protocols, reports, and procedures.
• Demonstrated project leadership and cross-functional collaboration skills.
• Onsite presence required: 5 days/week in Clayton, NC.

Responsibilities

• Prepare, execute, analyze and report IQ/OQ/PQ protocols and data.
• Own Change Requests related to validation activities and deliverables.
• Author and review Validation Plans, PQMPs, protocols, and validation documentation.
• Execute validation activities for critical systems, equipment, and processes to meet timelines.
• Perform compliance reviews and technical approvals of protocols and data.
• Lead investigations, deviations, and non-conformances using root cause analysis.
• Ensure activities comply with regulatory requirements.
• Create/update 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 for new systems and equipment implementations.

Skills

Validation lifecycle

Project leadership

Root cause analysis

Cross-functional collaboration

Documentation writing

Regulatory compliance

Change control

Communication

Education

Bachelor's degree in Engineering/CS

Master's degree preferred

Job description

Piper Companies is seeking a Senior Validation Engineer to lead validation strategy and execution within a GMP pharmaceutical environment, focusing on fill/finish, equipment qualification, and process validation.

This long-term W2 contract role is onsite in Clayton, NC, offering opportunities to drive validation efforts from commissioning through PQ, authoring and approving critical documentation, and ensuring regulatory compliance across manufacturing systems.