Quality Validation Engineer II

Essential 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.

Additional Responsibilities

• Other duties as needed

Minimum Preferred Qualifications - - Education/Experience:

• Bachelor’s degree in engineering, science, or related discipline
• Not less than five (5) years’ 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)

Minimum Preferred Qualifications - - Skills:

• 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

Supervisory Responsibility

• This position has no supervisory responsibilities 

Supervision Received

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

Working Environment

• Primarily office
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

Physical Demands

• 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

Position Type and Expected Hours of Work

• This is a full-time position
• Some flexibility in hours is allowed, by the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required