Job Description

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.

We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations.

We are currently looking for an entry-level CSV Engineer to join our team. 

RESPONSIBILITIES

• Write Validation Protocols such as IQ, OQ and PQs and associated test scripts 
• Execute Validation Protocols such as IQ, OQ and PQs to ensure compliance and adherence with applicable guidelines 
• Excel Spreadsheet Generation and Summary Report Writing for PQ studies 
• Review and modify Standard Operating Procedures (SOPs) 
• Generate test procedures to validate new or previously invalidated processes 
• Write risks assessments and applicable test scripts according to GLP & 21 CFR Part 11 compliance guidelines and the Validation Master Plan. 
• Prepare validation summary reports for executed protocols. 
• Communicate Computer System Validation approaches and requirements during planning/audits. 
• Knowledge of Veeva Vault and/or CRM systems is a huge plus. 
• Should be a fast learner of systems like Veeva Vault and CRM 
• Knowledge of Clinical Safety/Pharmacovigilance procedures and systems is a huge plus.

Requirements

• Minimum Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, etc.), Computer Sciences, or Life Science major (Biochemistry, Chemistry, Pharmacy, etc.) 

• Excellent GPA with strong professional recommendations. 

• Self-starter. 

• Computer System Validation (CSV), 21 CFR Part 11 regulation knowledge. 

• Leadership experience is a plus. 

• Interested in making a contribution to the company while learning. 

• Interested in learning validation and other activities required for companies to be compliant with Food and Drug Administration (FDA) regulations. 

• Strong communication and interpersonal skills. 

• This is a remote position.