PSC is a leading life sciences consulting andIT services company. For over 20 years we have been engaged in providing project, process, IT, engineering and validation support to top-tier pharmaceutical and biotech companies. We are seeking Validation Engineers with experience developing master plans, preparing protocols, analyzing test results, and preparing technical reports.
We are looking for a CSV Manager/Team Lead who will be responsible for overseeing Global LabWare LIMS initiatives for our customer. This person will be instrumental in providing strategic direction in conjunction with Senior management. This person should have prior GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.
No C2C, No sponsorship, No Third Party Resumes
- Write Validation Protocols such as IQ, OQ and PQs
- 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 unvalidated processes
- Write risks assessments and applicable test scripts according to GLP and 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.
Education and Experience:
- Minimum Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, etc.), Computer Sciences, or Life Science major (Biochemistry, Chemistry, Pharmacy, etc.)
- Computer System Validation with strong pharmaceutical / Med Device industry experience
- Experience with 21 CFR Part 11 regulation/ EU regulations required.
- 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
"PSC Biotech is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.”
Job Type: Contract
Salary: $80,000.00 to $100,000.00 /year
- CSV: 5 years (Preferred)
- GMP (Good Manufacturing Practice): 5 years (Required)