Validation Coordinator

Validation Coordinator

We are searching for an experienced Validation Coordinator at our Feasterville facility. 

Primary Duties and Responsibilities: 

Position Summary
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.

Primary 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
  

Basic Qualifications
Validation Coordinator:

- 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

Validation Coordinator, Sr:

- 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 Qualifications

- 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

Physical Requirements

- Employee is required to stand, bend, kneel, walk, sit, balance, handle or feel objects; tools or controls; reach with hands and arms.
- Employee must be able to lift and/or move up to 10 lbs.

Working Conditions

- Prolonged periods of sitting at a desk and working on computer
- Visits to the manufacturing floor

Special Requirements

- Ability to work evenings and/or weekends
- Ability to travel

Disclaimer
This job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this position.  This job description is subject to change but remains in effect until superseded or canceled in writing by your local Human Resources Representative or the Director of Global Human Resources.

Hourly

Hourly

21.00 - 32.00

Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.