Process Development Sr. Scientist

We are seeking a Process Development Sr. Scientist to support process development, process validation, technical documentation, and manufacturing support activities within a highly regulated manufacturing environment. This position offers the opportunity to work in a cross-functional setting, contributing to process improvements, validation initiatives, and commercial manufacturing readiness while ensuring compliance with quality and regulatory requirements. Responsibilities Support process development, process characterization, and process validation activities. Author, review, and execute validation protocols, technical documentation, and validation reports. Support equipment qualification and validation activities in compliance with GMP requirements. Analyze process performance data, identify trends, and recommend process improvements using scientific and risk-based approaches. Collaborate with Manufacturing, Quality, Engineering, and other cross-functional teams to support manufacturing readiness and process optimization. Participate in investigations, root cause analysis, CAPA activities, and implementation of corrective actions. Support change control activities and technical documentation updates. Contribute to continuous improvement initiatives that enhance process robustness, compliance, and operational efficiency. Support manufacturing operations during validation, characterization, and other critical production activities, including flexibility to work alternate shifts or weekends when required. Qualifications Doctorate (PhD, PharmD, or MD); OR Master's degree with 3+ years of relevant scientific experience; OR Bachelor's degree with 5+ years of relevant scientific experience. Degree in Engineering, Microbiology, or another related scientific discipline. Experience supporting validation activities in a highly regulated manufacturing environment. Experience developing and/or executing validation protocols and technical documentation. Knowledge of GMP requirements and quality systems. Strong analytical, technical writing, and problem-solving skills. Ability to work independently while collaborating effectively with cross-functional teams. Willingness to work different shifts and weekends during characterization or validation activities. Experience supporting pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments. Experience with process monitoring, process characterization, and continuous improvement initiatives. Knowledge of statistical tools such as Minitab or similar software. Experience with risk management methodologies and data analysis. Strong communication, organizational, and project management skills. If you are passionate about process development, validation, and scientific problem-solving in a regulated manufacturing environment, we encourage you to apply. Job Type: Full-time Pay: $55.00 - $60.00 per hour Education: Bachelor's (Preferred) Experience: supporting validation activities: 5 years (Preferred) developing and/or executing validation protocols: 5 years (Preferred) GMP requirements and quality systems: 5 years (Preferred) characterization: 5 years (Preferred) supporting pharmaceutical, biotechnology, medical device: 5 years (Preferred) process monitoring: 5 years (Preferred) statistical tools such as Minitab or similar software: 5 years (Preferred) risk management methodologies: 5 years (Preferred) data analysis: 5 years (Preferred) Work Location: In person