Onsite Aseptic Fill-Finish Validation Engineer

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k plan

Paid time off

Holidays

Sick leave

Job summary

Piper Companies seeks a Validation Engineer for a long-term contract at a leading pharmaceutical site in Clayton, NC. This fully onsite role requires you to be on site 5 days a week in Clayton, NC.

The engineer will execute IQ/OQ/PQ validation protocols for aseptic fill-finish equipment, support validation documentation, deviations, and change controls while collaborating with QA, Engineering and Manufacturing to ensure cGMP and FDA compliance.

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 (a validation lifecycle management system similar to Kneat) 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

Validation experience

Filling isolator equipment

Optima filling lines

TIMS familiarity

Regulatory knowledge

Tools

TIMS

Kneat

Job description

Piper Companies seeks a Validation Engineer for a long-term contract at a leading pharmaceutical site in Clayton, NC. This fully onsite role requires you to be on site 5 days a week in Clayton, NC.

The engineer will execute IQ/OQ/PQ validation protocols for aseptic fill-finish equipment, support validation documentation, deviations, and change controls while collaborating with QA, Engineering and Manufacturing to ensure cGMP and FDA compliance.