Validation Engineer – Oral Solid Dose Startup | Kneat | GMP

About Us

Founded in Eastern North Carolina in 1995, we are a trusted Commissioning, Qualification, and Validation (CQV) partner serving the pharmaceutical, biotechnology, and life sciences industries. For over 30 years, we have helped clients successfully bring manufacturing facilities, equipment, utilities, and processes from construction through commercial production while maintaining the highest standards of quality and regulatory compliance.

Our team specializes in startup and operational readiness, providing expertise in commissioning, qualification, validation, quality systems, and project execution for both greenfield and brownfield manufacturing projects. We pride ourselves on delivering practical, compliant solutions that accelerate project timelines, reduce risk, and help our clients achieve production goals faster.

As a company built on integrity, technical excellence, and client partnership, we invest in our people and foster a collaborative environment where experienced professionals can make a meaningful impact on some of the most advanced pharmaceutical manufacturing facilities in the industry.

Whether supporting emerging biotech companies or global pharmaceutical manufacturers, our mission remains the same: working for a greater purpose by providing managed services that impact people’s lives.

Why Join Us?

Joining our team means becoming part of a company with deep roots in Eastern North Carolina's thriving life sciences sector and a reputation for delivering results on critical manufacturing projects. Our teammates have the opportunity to work alongside industry-leading pharmaceutical and biotechnology companies, gain exposure to cutting-edge manufacturing technologies, and contribute directly to the successful startup and operation of facilities that produce life-saving therapies. We offer a culture built on teamwork, accountability, professional development, and the belief that our people are our greatest asset. If you are passionate about quality, compliance, and making an impact in pharmaceutical manufacturing, we invite you to grow your career with us.

About The Job

This is a highly specialized Validation Engineer position. Candidates without direct pharmaceutical CQV experience, Oral Solid Dose manufacturing experience, and the required software experience are unlikely to be considered.

We are seeking an experienced Validation Engineer to join our team in support of a major pharmaceutical manufacturing startup project focused on the commercial production of oral solid dose (OSD) products, including tablets and capsules. This role will be instrumental in bringing a new manufacturing operation from qualification through production readiness while ensuring compliance with FDA and cGMP requirements.

The successful candidate will work closely with Engineering, Quality, Manufacturing, and Automation teams to execute validation activities supporting Manufacturing Equipment, HVAC, Clean Utilities, Building Management Systems, and facilities qualifications. This position offers the opportunity to play a key role in the launch of a state-of-the-art pharmaceutical manufacturing facility and directly contribute to delivering life-changing therapies to patients.

Key Responsibilities

• Develop, execute, and review commissioning, qualification, and validation protocols and reports.
• Support qualification activities for manufacturing equipment, utilities, and facility systems associated with oral solid dose manufacturing.
• Lead validation efforts utilizing Kneat validation software, ensuring accurate and compliant electronic documentation.
• Manage project deliverables, schedules, and validation milestones using Smartsheet project management tools.
• Execute and support commissioning and qualification activities for, manufacturing equipment, Building Management Systems (BMS), HVAC systems, and clean utilities.
• Collaborate with Quality Assurance to ensure validation activities align with regulatory expectations and site quality requirements.
• Support risk assessments, discrepancy investigations, change controls, and CAPA activities related to validation.
• Participate in startup readiness reviews and cross-functional project meetings.
• Ensure all validation documentation complies with GDP, ALCOA , cGMP, and applicable regulatory standards.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 3 years of pharmaceutical validation or CQV experience.
• Hands-on experience with Kneat validation software.
• Proficiency using Smartsheet for project tracking and coordination.
• Demonstrated experience supporting Oral Solid Dose (OSD) manufacturing operations, including tablet and capsule production processes.
• Strong understanding of Building Management Systems (BMS), HVAC qualification, and facility validation.
• Working knowledge of FDA, cGMP, and data integrity requirements.
• Experience working within a quality-driven pharmaceutical manufacturing environment.

Preferred Qualifications

• Startup, expansion, or greenfield pharmaceutical facility experience.
• Experience supporting technology transfer and process validation activities.
• Strong communication and stakeholder management skills.

This is an excellent opportunity for a validation professional who thrives in fast-paced startup environments and enjoys seeing projects progress from construction and qualification through successful commercial manufacturing operations.