Validation Coordinator
About The Position
The Validation Coordinator is responsible for drafting and reporting on validation activities (Operational Qualification and Performance Qualification). The primary focus will be on OQ/PQs with limited interaction with Installation Qualification (IQ). This role ensures all validation projects are completed in compliance with internal QMS and customer requirements. The Validation Coordinator will review and understand customer protocol requirements and create an Oliver HCP validation protocol that incorporates the customer requirements while ensuring Oliver HCP procedures and processes are adhered to. They will be responsible for collaboration with the applicable global manufacturing location planning, process engineering, and operations team to schedule and perform the OQ/PQ validation. Once the product has been manufactured and is available for testing, the coordinator will ensure that the data is tested to the requirements of the protocol. The coordinator is also responsible for performing basic troubleshooting and root-cause analysis for any data anomalies or failures and working with the team to resolve issues and complete validation protocols successfully.
Requirements
- High school diploma or GED required
- 0-3 years of work experience in a manufacturing, quality assurance, or lab setting
- Basic understanding of statistics for data analysis
- Proficiency in reading and interpreting technical documents, including validation protocols, work instructions, and engineering drawings
- Strong problem-solving and mathematical skills necessary for troubleshooting and data analysis
- Excellent attention to detail and a commitment to accurate documentation
- Ability to communicate Oliver HCP validation process and validation requirements to internal and external customers
Nice To Haves
- Associate's degree in a relevant field (e.g., Engineering, Life Sciences, or a related technical discipline)
- Experience in a regulated industry, such as medical devices or pharmaceuticals
- Direct experience with quality systems, Good Manufacturing Practices (GMP), or ISO standards (e.g., ISO 13485)
- Experience with statistical software (e.g., Minitab, JMP)
- Strong technical writing skills
Responsibilities
- Coordinates and executes all validation activities by communicating with affected departments globally, which may include process engineering, operations, quality, and planning
- Drafts validation protocols and reports. This may include IQ, OQ, PQ, and other validation documents (PPAPs, PSWs, etc.)
- Perform data analysis using appropriate statistical tools and methods to determine if testing results meet acceptance criteria
- Conducts basic troubleshooting and investigation into data anomalies or failures and assists in root cause identification and remediation
- Collaborates with the validation team and other departments to ensure all testing is performed correctly and in compliance with protocol requirements
- Maintains project documentation and provides status updates to internal and external teams as needed
- Actively participates in customer meetings to understand the validation requirements and present results
- Prepares and presents validation project updates for customer meetings
- Assists with testing as required
- Supports site Quality teams on internal validation efforts in response to CAPA’s, new materials, supplier changes, or engineering trials as needed
- Supports internal audits when required
- May support customer complaints assisting the site quality teams in root cause analysis and investigations
- Additional duties as assigned by manager
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
1,001-5,000 employees
