Engineer III, Validation

Description

The role sits on the Validation Engineering team in Greenville, North Carolina, ensuring pharmaceutical manufacturing is reliable and compliant through commissioning, qualification and validation (CQV).

You will support validation across the site for manufacturing equipment, facilities, utilities, storage, automation controls and related systems, working alone and with cross-functional groups in an aseptic processing setting.

The team works closely, treats each other with respect and focuses on improving site processes together.

Work schedule is standard, Monday to Friday.

Environment: the cleanroom bans hair products, jewelry, makeup, nail polish, perfume, exposed piercings and facial hair. Cold rooms and freezers run at -22°F / -6°C. Office work is also part of the role. Some PPE is required, such as safety glasses, gowning, gloves, lab coat and ear plugs.

Adherence to Good Manufacturing Practices (GMP) safety standards applies throughout.

The company develops science-based solutions for environmental protection, food safety and cancer research.

Responsibilities

• Plan, write, review and carry out commissioning, qualification and validation protocols and their documents for equipment, facilities, utilities, storage and manufacturing processes.
• Confirm that validation work tied to projects and quality tasks is accurate, complete and follows site procedures and cGMP expectations.
• Help qualify and verify automation controls and computer systems used with process equipment in pharmaceutical manufacturing.
• Build and apply risk assessments to set validation strategy, test scope and controls.
• Work with Engineering, Manufacturing, Quality, Automation and other groups on individual and team validation tasks.
• Look into issues, run root cause analysis and support corrective actions and continuous improvement.
• Give technical support for project delivery, equipment start-up and validation readiness, including possible Factory Acceptance Testing (FAT).
• Keep technical records ready for inspection and support client or regulatory audits when needed.
• Grow your knowledge of aseptic processing, automated visual inspection (AVI), packaging and cold storage, with exposure to Optima or IMA platforms where relevant.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Chemistry or a related technical field.
• At least 5 years of relevant experience in validation, CQV, engineering or a closely related role in pharmaceutical, biotech or another highly regulated industry.
• Hands-on experience writing, reviewing and executing validation or qualification protocols, including IQ/OQ/PQ or equivalent lifecycle documents.
• Experience validating manufacturing equipment, facilities and utilities. Automation controls or computer system validation experience is a plus.
• Experience coordinating complex technical work across teams.
• Equivalent mixes of education, training and substantial work experience may be considered.
• Working knowledge of cGMP and regulated pharmaceutical manufacturing practice.
• Strong technical writing skills, producing clear, accurate, inspection-ready records.
• Ability to apply engineering principles, risk assessment, problem solving and root cause analysis to validation.
• Strong verbal and written communication, and the ability to work respectfully with technical and non-technical colleagues.
• Ability to manage priorities, work independently and contribute in team projects.
• Proficiency with Microsoft Office and relevant engineering or validation software.
• Preferred: experience with aseptic processing, AVI, packaging, cold storage, Optima or IMA equipment.
• Preferred: experience supporting regulatory inspections or client audits, and familiarity with continuous improvement methods.
• Experience from other highly regulated technical settings may be considered when it shows strong engineering principles and procedural compliance.
• Competencies: accountable and self-directed, collaborative and respectful, quality and compliance focused, strong problem solver, effective communicator, eager to learn and broaden technical skills.

Conditions

Full-time, onsite in Greenville, NC, generally Monday through Friday during normal business hours, with flexible scheduling based on business needs and task completion.

Roughly three months of role-specific onboarding and training, then ongoing learning through hands-on project work and cross-functional exposure.

Site-wide scope across a technically varied pharmaceutical manufacturing environment.

Travel is expected to stay under 10% and may include FAT or other project work.

Work in controlled or cleanroom areas may be required depending on assignments.

The company provides equal opportunity to all applicants.