Process Development Scientist

Job Description

We are seeking a Process Development Scientist to support process development activities within a highly regulated environment. The selected candidate will be responsible for supporting the design, execution, and documentation of validation, qualification, and process characterization activities, ensuring compliance with regulatory and quality requirements.

This role requires frequent interaction with suppliers and other manufacturing sites, requiring strong communication and collaboration skills.

Responsibilities

• Develop, execute, and document validation and qualification protocols for processes and equipment.
• Support qualification and characterization activities for vision inspection systems.
• Prepare technical documentation in compliance with regulatory and quality standards.
• Support Commissioning, Qualification, and Validation (CQV) activities, including protocol authoring and execution.
• Collaborate with cross-functional teams and external sites to ensure successful project execution.
• Maintain accurate and compliant technical documentation aligned with regulated industry standards.
• Participate in troubleshooting and technical problem-solving related to processes and equipment.
• Communicate effectively with suppliers and internal/external stakeholders.

Requirements

• PhD in Sciences or related field OR Master’s degree in Sciences + 2 years of scientific experience OR Bachelor’s degree in Sciences + 4 years of scientific experience
• Experience in a regulated industry (pharmaceutical, biotechnology, or similar).
• Experience creating and executing validation and qualification documentation.
• Strong written and verbal communication skills.
• Experience working with suppliers and cross-functional or multi-site teams.
• Knowledge of automated vision inspection systems.
• Knowledge of Computer System Validation (CSV).
• Experience supporting CQV documentation and execution.

Job Type: Full-time

Pay: $40.00 - $46.00 per hour

Education:

• Bachelor's (Preferred)

Experience:

• creating and executing validation : 5 years (Preferred)
• qualification documentation: 5 years (Preferred)
• working with suppliers and cross-functional : 5 years (Preferred)
• automated vision inspection systems: 5 years (Preferred)
• Computer System Validation (CSV): 5 years (Preferred)
• supporting CQV documentation and execution: 5 years (Preferred)
• regulated industry (pharmaceutical, biotechnology: 5 years (Preferred)

Work Location: In person