Seeking an Equipment Validation Engineer

Job Description

Provide ongoing Quality Engineering support to process development and design transfer from Research and Development to Commercial Production. Ensure products and processes conform to regulatory filing requirements and customer specifications. Product types will include pharmaceutical and medical devices, with a focus on transdermal and oral thin films, including mixing, coating, slitting, converting, and packaging. Development activities will cover product development, process feasibility, optimization, registration, and validation. Additionally, provide insight and support to equipment and facilities initiatives such as qualification and change control assessment, improving manufacturing documentation and standardizing robust methodologies.

Responsibilities

• Support process development and design transfer from R&D to Commercial Production.
• Ensure products and processes meet regulatory filing requirements and customer specifications.
• Focus on transdermal and oral thin films development, including mixing, coating, slitting, converting, and packaging.
• Involve in product development, process feasibility, optimization, registration, and validation.
• Provide support to equipment and facilities initiatives, including qualification and change control assessment.
• Improve current internal practices and procedures to enhance manufacturing documentation.
• Standardize robust methodologies for manufacturing processes.

Essential Skills

• 4+ years of experience in Quality Assurance and Medical/Pharma Capital Automated Equipment Validation.
• Experience in equipment qualification and validation work.
• Experience with large-scale automated equipment (e.g., air handlers, cartoning lines, tableting equipment).
• Familiarity with facility qualifications, including clean room requirements and regulatory specifications.
• 5+ years of quality experience in a regulated pharmaceutical, biopharmaceutical, or medical device position.
• Knowledge of manufacturing equipment and processes, increasing with each level.
• Working knowledge of cGMP, ISO, ISPE, ANSI/ASQ standards and guidelines.
• Experience with regulatory agencies, filing pathways, and diverse product types.

Additional Skills & Qualifications

• Experience leading qualification efforts on equipment, systems, and software.
• Knowledge of Good Automated Manufacturing Practice (GAMP).
• Experience with Continued Process Verification reports and Process Validation reports.
• Proficiency in statistical software (e.g., Minitab) is preferred.
• Experience with software validation is a bonus.
• Strong skills in technical writing, including risk assessments, protocols, and reports.