Validation Engineer - 177103

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Holidays and sick leave as required

Job summary

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

You will execute IQ/OQ/PQ validation for aseptic fill-finish equipment, support validation documentation and change controls, and collaborate with QA, Engineering, and Manufacturing to ensure GMP compliance and FDA standards.

Qualifications

• 7 years of validation experience in aseptic pharma manufacturing.
• Strong understanding of regulatory requirements and validation best practices.
• Experience with filling isolator equipment is highly preferred.

Responsibilities

• Execute IQ/OQ/PQ validation protocols for aseptic fill-finish equipment.
• Support validation documentation, deviations, and change controls.
• Collaborate with QA, Engineering, and Manufacturing to ensure compliance.

Skills

7+ years validation experience

cGMP/FDA knowledge

cross-functional collaboration

Tools

TIMS

Kneat

Optima filling lines

Job description

Piper Companies is seeking a Validation Engineer for a long-term contract opportunity at a leading pharmaceutical manufacturing site in Clayton, NC. The Validation Engineer will support the execution of validation protocols for aseptic fill-finish equipment, ideally including filling isolators and Optima filling lines. The Validation Engineer role is a fully onsite position, requiring you to be onsite 5 days a week in Clayton, NC.

Responsibilities for the Validation Engineer Include:

• 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.

Requirements for the Validation Engineer Include:

• 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.

Compensation for the Validation Engineer Includes:

• Salary range: $135,000 - $155,000
• Comprehensive benefits: Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.

Key words: Validation, validation engineer, aseptic manufacturing, pharmaceutical manufacturing, fill finish, equipment validation, IQ/OQ/PQ Protocols, GMP compliance, FDA regulations, filling isolator equipment, optima filling lines, cleanroom validation, process validation, equipment qualification, validation lifecycle, TIMS, Kneat

#LI-BH1

#ONSITE