Full-Time
Validation Consultant
Artech Information System
1,001-5,000 employees
IT staffing and project-based workforce solutions
No salary listed
Wake Forest, NC, USA
In Person
Category
 Biology & Biotech (3) |
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Required Skills
Word/Pages/Docs
Excel/Numbers/Sheets
Requirements
- Bachelor of Arts or Bachelor of Science in a technical or scientific discipline or related work experience
- Minimum of 3 years experience in Manufacturing validation in the Pharmaceutical or Healthcare Industry
- Working knowledge of current Good Manufacturing Practices regulations
- In-depth knowledge of process, packaging, facility, and cleaning validation
- Good computer skills including Microsoft Word, Excel, and PowerPoint
- Quality and detail oriented with strong documentation skills
- Excellent written and oral communication skills
- Ability to develop and facilitate validation training
- Flexibility to work extended hours to achieve results
- Proven project management experience in leading, researching, developing, data analysis, and executing GMP / System Life Cycle / Validation documentation and reports for utilities systems including Verification Protocols (VP), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Hands-on validation experience for utilities systems and supporting automation processes including Heating, Ventilation, and Air Conditioning systems; compressors; Water systems; Dust collectors; Building Management System (BMS) such as Rockwell Automation and Global Experience Management; Environmental Monitoring Systems (EMS) such as Rockwell Automation and Global Experience Management; laboratory instrumentation; temperature and humidity profiling for facilities, chambers, and process equipment
- Ability to perform calibrations and generate calibration reports
- Knowledge of Engineering Technology
- Advanced understanding and skills with Microsoft Word and Excel
- Knowledge of cGMP’s/Food and Drug Administration and other Regulatory requirements, and Quality Systems
- 2 years Pharmaceutical Quality Assurance experience
- BA/BS with 5 years Pharmaceutical experience or MS with 3 years Pharmaceutical experience or related experience
- Knowledge of Engineering Technology
Responsibilities
- Ensure that the GSK Zebulon - Building Management System (BMS) Replacement Project commissioning / validation program meet all regulatory and local requirements.
- Responsible for the development, planning, and implementation of commissioning, qualification and validation for the manufacturing, packaging, facilities, computer controls, and cleaning processes.
- Write, review and execute documentation to conduct all commissioning and / or validation activities to support equipment modification / upgrade projects and maintain existing validated states.
- Drive all aspects of the Commissioning Life Cycle and / or Validation Life Cycle from design through operation and improvement, including developing, updating, and maintaining the Project Validation Master Plans and Project Commissioning Master Plans.
- Coordinate resources needed to complete commissioning and / or validation tests; provide commissioning / validation support during the design, evaluation, and procurement stages; monitor commissioning /validation criteria and assure compliance.
- Collaborate with Engineering on the development of Installation and Operational Qualification documents; write and execute process, packaging, computer, facility, and cleaning validation protocols and summary reports.
- Interface with Manufacturing, Packaging, Logistics, Engineering, and external vendors to facilitate and drive protocol execution.
- Author, review, revise, or approve Standard Operating Procedures (SOPs) as required.
- Maintain up to date knowledge of commissioning and validation requirements, practices, and procedures and instruct other members of the project team.
- Develop and implement improvement initiatives with filling/packaging/computer and facility/utility validation activities.
- Manage simultaneous projects; participate on cross-functional teams to address problems, facilitate discussion and research, and improve procedures and inter-department relationships
Desired Qualifications
- Prior experience at the Zebulon site and possession of current hard badge are preferred
- 2 years Pharmaceutical QA experience
- Experience with validation training development and delivery
- Experience with regulators engagement and inspections
Artech Information System provides IT staffing and project-based services worldwide. It connects organizations with tech talent through staffing programs (contingent, direct hire, RPO, master vendor, payroll transition) and delivers end-to-end digital and technical projects (design, operations, development, and platforms). It stands out through its focus on applied human intelligence, diverse and inclusive culture, and a track record with Fortune 500 clients across multiple countries. Its goal is to be the ecosystem that connects people, technology, and opportunities, enabling global businesses and talent to grow together.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Morristown, New Jersey
Founded
1992
Simplify's Take
What believers are saying
- Artech provides managed cloud and cybersecurity services to Fortune 500 firms.
- Artech supports public-sector organizations amid AI and cloud shifts.
- Artech generated over $775 million in global revenue as women-owned business.
What critics are saying
- Trump's 2025 H-1B tightening cuts Artech's India staffing in 3-6 months.
- Apex Group acquisitions erode Artech's position in 12-24 months.
- 2026 recession freezes Fortune 500 IT budgets, hitting Artech revenue.
What makes Artech Information System unique
- Artech is the largest women-owned IT workforce solutions firm in the U.S.
- Artech holds Great Place to Work certification for its dynamic culture.
- Artech expanded India offices in Bengaluru, Bhopal, Hyderabad, and Chennai.
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Benefits
Remote Work Options