Oliver Healthcare Packaging · 2 weeks ago
Validation Coordinator
Oliver Healthcare Packaging is seeking an experienced Validation Coordinator for their Feasterville facility. The role involves coordinating and executing validation activities, ensuring compliance with internal quality management systems and customer requirements, and collaborating with various departments to perform validation testing.
Health CareManufacturingMedicalPackaging Services
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
Qualification
Required
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
Minimum of 5 years of work experience in a validation or related quality assurance role
Strong understanding of statistical analysis
Demonstrated ability to communicate effectively with both internal teams and external customers with minimal supervision
Ability to speak to customers on validation requirements and present validation results with minimal supervision
Proven track record of successful project management and execution of complex validation activities
Coordinate with the Customer Care Representative and/or Sales team to generate quoting as needed
Preferred
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
Company
Oliver Healthcare Packaging
Oliver Healthcare Packaging is a medical product packaging company.
H1B Sponsorship
Oliver Healthcare Packaging 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 (2)
Funding
Current Stage
Late StageRecent News
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