CQV Engineer (Commissioning, Qualification & Validation)

Job Summary

We are seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities within an aseptic pharmaceutical manufacturing environment. This role is responsible for ensuring that equipment, utilities, and laboratory systems are installed, tested, and operated in compliance with GxP, FDA, and applicable regulatory requirements. The ideal candidate will have hands-on experience in aseptic processing and validation lifecycle execution within a regulated industry.

Responsibilities

• Execute commissioning and qualification (C&Q) activities for aseptic manufacturing equipment, utilities, and systems
• Develop, review, and execute IQ, OQ, and PQ protocols in alignment with regulatory and company standards
• Support startup and validation of black utilities, including water-for-injection (WFI), clean steam, and process gases
• Perform qualification activities for laboratory analytical instruments and equipment
• Collaborate with cross-functional teams including Engineering, Quality Assurance, Validation, and Manufacturing
• Ensure all activities comply with GxP, FDA regulations, and industry standards
• Utilize electronic validation systems such as Kneat for protocol execution and lifecycle documentation
• Troubleshoot and resolve issues encountered during commissioning and qualification phases
• Maintain accurate and complete documentation to support audits, inspections, and regulatory requirements

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field, or equivalent combination of education and experience
• Minimum of 5 years of experience in commissioning, qualification, and/or validation within the pharmaceutical or biotechnology industry
• Hands-on experience in aseptic manufacturing environments
• Strong knowledge of GxP, FDA regulations, and validation lifecycle principles
• Experience with black utilities such as WFI systems, clean steam, and process gases and/or laboratory equipment qualification
• Strong technical writing, communication, and problem-solving skills
• Ability to work independently and collaboratively in a team environment

Work Requirements

• Ability to work onsite in Lehigh Valley, PA on a full-time basis
• Ability to comply with all site safety, quality, and regulatory requirements
• Ability to wear required personal protective equipment (PPE) and work in controlled environments, including cleanrooms, as needed
• Ability to perform tasks that may require standing, walking, or working in a manufacturing environment for extended periods

Salary/Rate

This is a good-faith pay range based on market data, experience level, and project scope. Actual compensation may vary based on qualifications, skills, and business needs, in accordance with applicable laws.

Benefits

This is a contract position. Employer-provided benefits are not offered for this role unless otherwise required by applicable law.

Equal Opportunity Employer

We are an Equal Opportunity Employer and make employment decisions without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, genetic information, veteran status, or any other protected characteristic under applicable federal, state, or local laws.

Application

Qualified candidates are encouraged to apply by submitting a current resume. Applicants may request reasonable accommodations during the application or interview process in accordance with applicable laws.