Job Summary:
We are seeking a highly motivated and detail-oriented Validation & Process Engineer to join our team. The ideal candidate will be responsible for preparing and executing equipment validation protocols, performing process characterization, updating key documents like BOMs and DMRs, and supporting product lifecycle management (PLM) activities. This role plays a critical part in ensuring that equipment and processes meet the highest standards of quality and compliance.
Key Responsibilities:
- Preparation and Execution of Equipment Validation Protocols:
- Develop and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment validation.
- Ensure that all validation activities comply with industry standards and regulatory requirements.
- Development & Execution of Test Method Validations:
- Create and implement test method validation protocols to ensure reliable and reproducible testing methods.
- Collaborate with quality, R&D, and manufacturing teams to ensure accurate execution and results analysis.
- Process Characterization and Design of Experiments (DoE):
- Perform process characterization and identify key process variables that influence performance.
- Design, execute, and analyze experiments using Design of Experiments (DoE) methodologies to optimize processes and equipment performance.
- BOM (Bill of Materials) & DMR (Device Master Record) Updates:
- Maintain and update Bill of Materials (BOM) and Device Master Record (DMR) documents to reflect any changes in processes, materials, or equipment.
- Ensure all documentation is current and aligns with company standards and regulatory guidelines.
- Support in Protocol Execution & Report Generation:
- Assist in the execution of validation and test protocols.
- Prepare detailed validation reports and ensure that all findings, data, and results are properly documented.
- PLM (Product Lifecycle Management) System Activities:
- Support Product Lifecycle Management (PLM) activities including Change Orders (CO), report routing, and follow-up on approvals.
- Ensure all necessary approvals are obtained and documentation is updated within the PLM system.
Required Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 3+ years of experience in equipment validation, process characterization, or a similar role in the medical device, pharmaceutical, or manufacturing industry.
- Strong knowledge of validation processes and protocols (IQ/OQ/PQ).
- Experience with Test Method Validation (TMV) and statistical analysis.
- Familiarity with Design of Experiments (DoE) techniques for process optimization.
- Knowledge of PLM systems and Change Order (CO) processes.
- Strong attention to detail and ability to document protocols and reports clearly.
Preferred Qualifications:
- Experience in regulated industries such as medical devices or pharmaceuticals.
- Knowledge of ISO 13485, FDA regulations, or other relevant regulatory standards.
- Proficiency in software tools like Minitab, JMP, or similar for statistical analysis.
- Experience with BOM and DMR management.
Skills & Competencies:
- Excellent analytical and problem-solving skills.
- Strong organizational skills with the ability to manage multiple tasks simultaneously.
- Effective communication and collaboration skills, with the ability to work across departments.
- Ability to work independently and take ownership of complex projects.
- High attention to detail and a commitment to producing quality work.