• Collaborate with cross-functional teams to gather/align information and gain thorough understanding of technical requirements. 
• Write, develop, review, and approve technical documentation including but not limited to CQV protocols, user requirement specifications, functional specifications, equipment specification documentation, procedures, summary reports, and so on. 
• Proactively ensure accuracy and completeness of all required technical documentation.
• Manage documentation updates and revisions.
• Execute required commissioning, qualification, and validation protocols for a range of specialty and process equipment. 
• Conduct site and factory acceptance testing. 
• Additional responsibilities as required. 

Requirements

• Bachelor's degree in related engineering discipline. 
• 5 years of experience in a technical writing role and experienced executing CQV activities. 
• Experienced with process equipment, including but not limited to CTUs, bioreactors, lyophilizers, chrome skids, etc.
• Expererience in the peptide manufacturing space is a plus. 
• Automation engineering background is a plus. 
• Experienced with a range of technical writing software and systems. 
• Knowledge of master controls. 
• Excellent technical writing skills, with strong attention to detail and commitment to quality and compliance. 
• Strong understanding of regulatory requirements.
• Excellent communication and interpersonal skills. 
• Ability to hit the ground running and work both independently and collaboratively in a fast-paced environment with changing priorities and deadlines.
• Strong organizational and time-management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
• 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