Senior Validation Engineer

Company Name: Liquidia Corporation

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

Job Summary

We are looking to hire a Validation/Sr. Validation Engineer with experience in Computer Systems Validation (CSV) and Data Integrity in a pharmaceutical manufacturing regulated environment operating within industry standards and regulatory requirements.

Responsibilities

• Computer Systems Validation (CSV): Building, planning, executing, and documenting validation activities for computer systems to ensure they meet with company procedures and regulations such as FDA, 21 CFR Part 11, EudraLex Volume 4: Anex 11, and ISPE GAMP 5 guidelines.
• Documentation: Preparing validation protocols, reports, and various documentation necessary for compliance. This includes, but is not limited to, validation plans, risk assessments, functional requirements, configuration specifications, and traceability matrices.
• Data Integrity: Ensuring the accuracy, completeness, and consistency of data to comply with regulatory standards and industry best practices.
• Risk Assessment: Conducting risk assessments to identify potential vulnerabilities within computer systems and implementing measures to mitigate risks.
• Compliance: Interpreting and applying regulatory requirements related to computer systems validation and data integrity, ensuring all systems are compliant with current guidelines.
• Continuous Improvement: Identifying opportunities for process improvements within the CSV framework and data integrity practices.
• Audit Support: Supporting internal audit readiness by providing necessary documentation and responding to audit inquiries.

Requirements

Education and Experience

• Educational Background: BS degree in engineering, computer science, or a related field.
• Experience: Proven experience in computer systems validation and data integrity within FDA regulated manufacturing environment.
• 5 yrs of experience (Validation Engineer)
• 7 yrs of experience (Sr. Validation Engineer)

Knowledge, Skills, and Abilities

• Knowledge: In-depth understanding of regulatory requirements, such as FDA 21 CFR Part 11, EudraLex Volume 4: Anex 11, GAMP, and other standards related to CSV and data integrity.
• Technical Skills: Proficiency in validation methodologies, risk assessment techniques, and data integrity tools.
• Analytical Skills: Strong analytical and problem-solving skills to identify and address validation and data integrity issues.
• Communication Skills: Excellent written and verbal communication skills for documentation and stakeholder engagement working with cross-functional teams.
• Attention to Detail: High level of attention to detail to ensure accuracy and completeness of validation activities and data integrity measures.

Benefits

Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

Recruiting Agencies, Please Note

Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.