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Oliver Healthcare Packaging · 1 week ago

Validation Coordinator

Feasterville-Trevose, PA

Full-time

Onsite

New Grad, Entry, Mid, Senior Level

$21/hr - $32/hr

0+ years exp

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

H1B Sponsor Likely

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

Validation protocolsStatistical analysisProject managementQuality systemsTechnical writingProblem-solvingAttention to detailCommunication skills

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.

Founded in 1890

Grand Rapids, Michigan, USA

501-1000 employees

https://www.oliverhcp.com

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)