EPL Bio Analytical Services · 1 month ago
Computer Systems Validation Engineer
Grand Prairie,TX,US
Full-time
Hybrid
Mid Level
$80K/yr - $85K/yr
3+ years expTentamus North America is searching for a skilled Computer Systems Validation Engineer to lead validation efforts, strengthen regulatory compliance, and support the implementation of high-quality, risk-based IT and laboratory systems. This role involves performing validation services, ensuring compliance with cGMP, and collaborating with cross-functional teams to enhance quality standards.
AgricultureBiotechnologyFood and Beverage
No H1B
Responsibilities
Perform validation services, including but not limited to equipment qualification, method validation, protocol generation and execution, data analysis and reporting; Generating, executing, and reviewing validation protocols and reports for equipment, instruments, utilities, and control systems through: Commissioning, (ERES), VP, FDS, DS, URS, IQ, OQ, PQ, VSR phases
Author, review, approve, and execute validation documentation, including protocols, summary reports, procedures, and other lifecycle documents
Design, implement, and support validation strategies and protocols for products, raw materials, and development projects
Provide URS, validation plans, and risk assessments for new systems and equipment introduced to the facility
Provide technical support for validation activities associated with Quality Control testing processes
Ensure validation studies and related activities comply with cGMP, quality systems, and IT Quality Assurance practices
Participate in and support internal and external audits and inspections, including identifying compliance gaps and implementing corrective actions
Assess site regulatory compliance status and ensure implementation of CAPA for ongoing inspection readiness
Identify, communicate, and manage trends in operational compliance risks, ensuring appropriate CAPA is agreed upon with stakeholders
Provide compliance input for internal management reviews and external regulatory inspections
Develop and implement quality standards, including SOPs and processes for IT products and services
Support and maintain the validation department's equipment inventory
Generate data and reports for validation system evaluation programs
Investigate and conduct troubleshooting and root-cause analysis for validation-related incidents and deviations
Resolve CAPAs and non-conformances related to validation activities
Partner with Quality Laboratories, QA, and cross-functional teams on validation study execution and quality initiatives
Represent equipment qualification and validation programs during client and regulatory audits
Utilize compliance expertise to guide program, project, and system owners in applying a risk-based approach to compliant IT solution delivery
Drive continuous monitoring, improvement, and digitalization of processes, services, and tools by applying LEAN methodologies and automation
Qualification
Required
3–5 years of experience in a laboratory, IT Quality Assurance, or related regulated environment, with the ability to perform all essential duties independently
Working knowledge of common laboratory equipment and software as well as general pharmaceutical testing processes, raw materials, and quality systems
Full working knowledge of 21 CFR Part 11, GAMP 5, ALCOA+ and standard industry expectations for computerized system validation
Strong understanding of the system validation lifecycle, computer system validation requirements, and data integrity principles
Ability to apply concepts from science and engineering to define problems, collect and analyze data, and draw valid conclusions
Proficiency with Quality Management tools and documentation practices
At least 2 years of professional experience in IT Quality Assurance, including proficiency with IT QA SOPs, Quality Policies, and delivering training to IT and laboratory users
Strong problem-solving, project management, and organizational capabilities
Ability to manage multiple priorities while balancing short- and long-term objectives
Able to work collaboratively in cross-functional and cross-cultural teams, while also making independent decisions when required
Excellent oral and written communication skills, with the ability to clearly synthesize and present complex concepts
Preferred
Bachelor's Degree in Chemistry, Laboratory Sciences, Computer Science, or a related field preferred; equivalent experience, post-graduate education, or relevant certifications/licensure considered
GMP experience strongly preferred
Benefits
A comprehensive and low-cost benefits package including medical, HSA, dental, vision, disability, life insurance, a matching 401(k), paid time off (PTO), and access to an Employee Assistance Program
Company
EPL Bio Analytical Services
EPL Bio Analytical Services provides analytical laboratory sevices.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase