Quality Validation Engineer II

BioAgilytix•Durham, NC

About The Position

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. Youâll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them. The Quality Validation Engineer II is responsible for providing quality assurance (QA) oversight of computer validations and equipment qualifications. He or she is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success and meets business needs. This role preferably needs to have hands-on experience in integrating AI/Machine Learning technologies in quality systems or laboratory processes under FDA regulatory requirements (e.g., 21 CFR Part 11) to support our efforts to scale and move the business forward.

Requirements

Bachelorâs degree in engineering, science, or related discipline
Not less than five (5) yearsâ experience in pharmaceutical/GxP/regulated environment
Direct hands-on experience with laboratory computer systems validation and/or equipment qualifications
Direct hands-on experience with GxP regulations (FDA, EPA, EU, ICH, USP, ASTM and ISO)
Knowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principles
Knowledge of IT infrastructure and information database systems
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies
Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
Advanced computer skills in Microsoft Office (Word, Excel, Outlook, etc.)
Excellent written and verbal communication skills
Versatility, flexibility, and willingness to work within changing priorities
Ability to deal effectively with a diversity of individuals at all organizational levels
Ability to work in an upright and/or stationary position for more than 8 hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
Frequent mobility required
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
Light to moderate lifting and carrying (or otherwise moves) objects including files and laptop computer with a maximum lift of 20 pounds
Ability to access and use a variety of computer software
Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress and multi-task
Regular and consistent attendance

Nice To Haves

This role preferably needs to have hands-on experience in integrating AI/Machine Learning technologies in quality systems or laboratory processes under FDA regulatory requirements (e.g., 21 CFR Part 11) to support our efforts to scale and move the business forward.

Responsibilities

Quality Guidance: Provide guidance in the development and authoring of procedures and policies for computerized systems and equipment, including validations, change control, and security measures.
Ensure that documents related to computer system and equipment validations follow GxP standards, as well as regulatory requirements such as 21 CFR Part 11, Annex 11, Annex 15, and GAMP.
Author validation documentation for new and existing computer systems/equipment, ensuring completeness, accuracy, and compliance with regulatory standards.
Oversee the computer system validation and equipment implementation, collaborating with various departments, consultants, and vendors to plan, implement, and complete validation/qualification projects for systems such as LIMS, ELN, and instrument or equipment software.
Act as a core resource for collecting and documenting requirements for a risk-based validation approach, ensuring thoroughness and accuracy in documentation.
Participate in investigations and assist in resolving issues related to validated systems, ensuring timely resolution and implementation of corrective actions.
Perform periodic reviews of validated computer systems and equipment, reviewing findings and ensuring completion of necessary follow-up actions.
Support quality reviews of Standard Operating Procedures (SOPs), policies, test protocols, and master plans for computer validation and equipment qualification, as needed.
Maintain accurate listings of Computer System Validation Status and Equipment Master Listings, ensuring completeness and accuracy of information.
Participate in the review and approval of change controls, deviations, and Out of Tolerances to ensure timely closure
Perform duties with minimal management oversight, demonstrating independence, initiative, and accountability in fulfilling responsibilities.
Other duties as needed