Onsite CQV Validation Engineer – GMP Pharma

ZP Group; Clayton (NC); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Full benefits package

Contract with potential extension

Job summary

Piper Companies is seeking a Validation Engineer for a leading pharmaceutical manufacturing organization in Clayton, NC. This onsite role focuses on CQV activities across facility systems, manufacturing equipment, and supporting utilities within GMP environments.

The successful candidate will lead IQ/OQ/PQ validation efforts, collaborate with engineering, QA, IT, and operations, and ensure data integrity and regulatory compliance in FDA/GMP contexts.

Qualifications

• 5+ years of validation experience in regulated manufacturing environments.
• Hands-on CQV projects for facility systems, manufacturing processes, or computerized systems.
• Knowledge of aseptic processing, filling, packaging, warehouse validation, or QC lab validation.
• Familiarity with cGMP, FDA guidance, GAMP 5, and data integrity requirements.
• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related technical discipline.

Responsibilities

• Lead commissioning, qualification, and validation activities for facility systems and equipment within GMP operations.
• Develop, execute, and review IQ/OQ/PQ protocols and validation plans.
• Support validation across aseptic formulation, filling, packaging, warehouse validation, and QC laboratories.
• Collaborate with engineering, QA, manufacturing, IT, and operations to meet timelines and regulatory expectations.
• Investigate deviations and maintain compliance with FDA/EU GMP standards.

Skills

CQV experience

GMP compliance

Aseptic processing knowledge

Validation documentation

Regulatory knowledge (FDA/GMP)

Education

Bachelor's degree (Engineering/Life Sciences/CS)

Job description

Piper Companies is seeking a Validation Engineer for a leading pharmaceutical manufacturing organization in Clayton, NC. This onsite role focuses on CQV activities across facility systems, manufacturing equipment, and supporting utilities within GMP environments.

The successful candidate will lead IQ/OQ/PQ validation efforts, collaborate with engineering, QA, IT, and operations, and ensure data integrity and regulatory compliance in FDA/GMP contexts.