BioAgilytix · 18 hours ago
Quality Validation Engineer II
Durham, NC
Full-time
Onsite
Mid, Senior Level
5+ years expBioAgilytix is a company dedicated to advancing science and delivering bioanalytical services for new medicine breakthroughs. The Quality Validation Engineer II will provide quality assurance oversight for computer validations and equipment qualifications, ensuring compliance with regulatory standards while collaborating with cross-functional teams to support business needs.
BiotechnologyLifestyle
Responsibilities
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
Qualification
Required
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)
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
Preferred
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)
Benefits
Medical Insurance (HDHP with HSA; PPO)
Dental Insurance
Vision Insurance
Flexible Spending Account (medical; dependent care)
Short Term Disability
Long Term Disability
Life Insurance
Paid Time Off (4 weeks per year)
Parental Leave
Paid Holidays (9 scheduled; 5 floating)
401k with Employer Match
Employee Referral Program
Company
BioAgilytix
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development.
1001-5000 employees
H1B Sponsorship
BioAgilytix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (8)
2023 (8)
2022 (6)
2021 (9)
2020 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2016-02-22Acquired
Leadership Team
Davide Molho DVM
Chief Executive Officer
Maureen Marchek
Chief Financial Officer
Company data provided by crunchbase