Senior Quality Assurance Engineer

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

The Sr. Quality Assurance Engineer position is responsible for performing activities within the Quality Department related to the functions of QA Validation & Compliance Programs supporting GMP Manufacturing. This is a technical Quality Assurance role with a primary function to ensure all documentation created and completed is technically accurate and compliant as per company Quality Management System (QMS) and other governing documents as applicable. This position requires a technically trained and detail-oriented person with strong communication and organizational skills.

The Sr. Quality Assurance Engineer position will directly support the QA Validation & Compliance department with planning, execution, and reporting activities, as well as providing technical QA oversight, ensuring compliance in project planning and execution of Change Control, Maintenance and Calibration activities with internal company Quality Systems, with FDA and other regulatory requirements.

Job Responsibilities

• Continuously evaluate and evolve Liquidia’s Validation/Compliance Policies, Programs, and Procedural level documents to ensure compliance with Liquidia QMS and regulatory expectations (FDA, Global etc.).
• Serve as internal subject matter expert on validation program compliance in support of partner and regulatory audits.
• Create/Revise, review and approve documentation in eQMS, including SOPs, Validation Plans and Protocols, Risk Assessment Documentation and Tools, Deviation/Root Cause Analysis/Investigations, Change Controls, and CAPAs.
• Partner closely and cooperatively across all departments to enable the entire team’s mutual growth, development, and overall success.
• Drive the validation program periodic quality review schedule and reporting cycles.
• Assist the QA department with assigned validation project planning and management efforts.
• Perform internal systems and compliance audits with efficiency and focus on critical risks.
• All other general Quality Assurance duties as assigned.

Job Responsibilities

Education and Experience

• BS degree in Engineering or Science and/or equivalent combination of education and experience required.
• 5 (five) or more years of related professional experience in a current Good Manufacturing Practices (cGMP) environment demonstrating increasing roles & responsibilities in Validation and Quality Systems Regulatory compliance programs.
• Experience with validation master planning around new product/process development and introduction (FDA Process Validation Stages), new facilities/critical utilities CQV, EMPQ, QC Equipment and Analytical Instrumentation qualification, manufacturing equipment validation, CSV associated with equipment/instrumentation software systems.
• Experience as lead resource in all phases of the Validation Lifecycle (Risk Assessment, Gap Assessment, IQ, OQ, PQ, PV, CV, CSV, etc.).
• Experience with Validation and Quality Compliance Principles/Practices related to GMP manufacturing of intermediate and finished product as well as GMP Product Supply Chain Data Integrity.
• Experience with planning, developing, and executing validation strategies for multiple phases of clinical development and GMP commercial supply chain required in either biotechnology, pharmaceuticals, or medical device industries.
• Lead contributor to Quality Systems work processes (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
• Ability to work both independently and/or collaboratively in a project oriented GMP manufacturing environment and apply work/task/project organizational skills to achieve quality outcomes while maintaining schedule flexibility/agility.

Knowledge, Skills, and Abilities

• Has knowledge, experience, and functional competencies around Facilities Equipment and Critical Utilities Engineering and CQV processes and terminology, Quality System regulations, GMP documentation and records management practices, and inspection readiness.
• Expertise in Quality System Change Control requirements in support of cGMP and/or GxP regulations.
• Relies on Pol/SOP instructions and other pre-established guidelines and documentation to perform the expected functions of the position role.
• Applies experience and knowledge of GMP Quality guidelines independently in planning and execution to assess and determine level of compliance required (strategic & tactical).
• Detail oriented with strong interpersonal, oral and written communication skills in a teamwork environment.
• Ability to organize and track multiple tasks in a dynamic teamwork environment.
• Competencies in Project Management and Six Sigma processes are a plus.

Benefits

Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off 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.