Process Engineer I - Validation and Risk Management - Compunnel : Job Details

Job Summary The Process Engineer I will apply process and regulatory compliance expertise to support both new and existing products, focusing on risk assessment and validation protocol development. This role is pivotal in ensuring product and process compliance with industry standards and regulations, supporting continuous improvement, and driving operational excellence. The engineer will collaborate with cross-functional teams to define, standardize, and implement validation and risk management practices that enhance product quality, safety, and cost-effectiveness. Key Responsibilities

• Lead and support risk assessment development (PFMEA) and validation protocols (IQ, OQ, PQ) for both new and legacy products.
• Collaborate with Quality, Engineering, and Operations teams to improve and standardize process methodologies and documentation.
• Provide technical leadership for assigned processes and serve as a process expert to drive plant performance improvements.
• Develop and execute experimentation and validation plans, including data analysis and technical reporting.
• Author validation protocols with statistical justification based on product specifications and risk assessments.
• Implement and document process, material, and equipment changes via formal change control systems.
• Ensure compliance with internal quality systems and external regulations (OSHA, ISO 13485, QSR, FDA, GMP, etc.).
• Support new product introductions (NPIs) through process certification, equipment installation, documentation, and team training.
• Act as a team member or leader on various cross-functional projects, driving process excellence and innovation.

Required Qualifications

• Education: Bachelor’s degree in Engineering or a related field (Mechanical, Electrical, Manufacturing, Chemical, Quality, or Process Engineering).
• Experience: Minimum of 2+ years in a process engineering, quality, or technical role in a manufacturing environment.

Strong experience in:

• Developing and completing PFMEA risk assessments.
• Drafting and executing IQ/OQ/PQ validation protocols.
• Authoring validation documentation with statistical justification.
• Familiarity with engineering tools and methodologies: DOE, SPC, DMAIC, data analysis, etc.
• Proficiency in Microsoft Office Suite, especially Excel (formulas, graphs, data manipulation).
• Demonstrated problem-solving and risk-based assessment capabilities.
• Strong time management, organization, and technical writing skills.

Preferred Qualifications (if any)

Experience in a regulated manufacturing environment, preferably medical device or pharmaceutical.

Exposure to Client technologies or previous employment at Client is a plus.

Project management experience or certification.

Training in statistical software (e.g., Minitab, JMP) for advanced analysis.

Certifications (if any)

• No certifications required. Certifications in Six Sigma, Risk Management, or Quality Engineering are considered a plus.

Education: Bachelors Degree Certification: Six Sigma Certification