• Develop and execute IQ, OQ, PQ protocols, ensuring adherence to regulatory and industry requirements. 
• Draft, review, and author protocols, procedures, summary reports, exceptions, risk assessments, and additional required technical documentation. 
• Support documentation updates as needed in required standard operating procedures, forms, and so on.
• Perform acceptance testing and evaluate qualification data and results, ensuring alignment with acceptance criteria. 
• Responsible for maintaining and developing qualification activity schedule. 
• Support additional cleaning validation tasks as needed.
• Proactively drive successful project completion and deliverables, taking on project coordinating tasks as required. 
• Additional responsibilities as required.

Requirements

• Bachelor's degree in related engineering discipline. 
• 3-5 years of commissioning, qualification, and validation engineering experience within the pharmaceutical manufacturing/life science industry. 
• Experienced in clean room qualification. 
• Experienced in environmental monitoring qualification.
• Cleaning validation experience is a plus.
• Proven technical writing skills in order to produce accurate and quality technical documentation including protocols, procedures, reports, etc. 
• Strong understanding of cGMP regulations and quality compliance. 
• Excellent communication skills, both verbal and written. 
• Strong attention to detail with a commitment to quality and accuracy.
• Excellent time management and organization skills. 
• Strong analytical, analyses, and problem solving skills. 
• ​At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.

Benefits