Onsite Validation Engineer — Aseptic Fill-Finish Systems

Zachary Piper Solutions; Clayton (NC); On-site; USD 135,000 - 155,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401k

PTO

Holidays

Sick leave

Job summary

Piper Companies seeks a Validation Engineer for a long-term contract at a leading pharmaceutical site in Clayton, NC. The role focuses on executing IQ/OQ/PQ validation protocols for aseptic fill-finish equipment, including filling isolators and Optima lines.

This is an onsite position, requiring presence in Clayton five days a week. Candidates should have at least seven years of validation experience in aseptic pharma manufacturing, familiarity with TIMS, and strong knowledge of regulatory

Qualifications

• 7 years of validation experience in aseptic pharma manufacturing.
• Experience with filling isolator equipment is highly preferred.
• Experience with Optima filling lines is a strong plus.
• Familiarity with TIMS (validation lifecycle management system) is desirable.
• Strong understanding of regulatory requirements and validation best practices.

Responsibilities

• Execute validation protocols (IQ/OQ/PQ) for aseptic fill-finish equipment.
• Support validation documentation, deviations, and change controls.
• Collaborate with cross-functional teams including QA, Engineering, and Manufacturing.
• Ensure compliance with cGMP, FDA, and internal quality standards.

Skills

7 years validation experience

Aseptic pharma manufacturing

IQ/OQ/PQ protocols

TIMS knowledge

Regulatory compliance

Tools

TIMS

Kneat

Optima filling lines

Job description

Piper Companies seeks a Validation Engineer for a long-term contract at a leading pharmaceutical site in Clayton, NC. The role focuses on executing IQ/OQ/PQ validation protocols for aseptic fill-finish equipment, including filling isolators and Optima lines.

This is an onsite position, requiring presence in Clayton five days a week. Candidates should have at least seven years of validation experience in aseptic pharma manufacturing, familiarity with TIMS, and strong knowledge of regulatory