Senior CSV Specialist

Weil Group, Inc; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Weil Group, Inc. is seeking a qualified candidate for computerized system validation and data integrity in pharmaceutical manufacturing. The role requires a Bachelor's degree in Science and deep knowledge of cGMP, FDA and data integrity regulations.

You will support validation efforts for laboratory, sterile and non-sterile operations and contribute to project management across teams. The ideal candidate brings 4+ years of validation experience, strong communication skills in English and

Qualifications

• Bachelor’s Degree in Science (Computer Systems or Engineering preferred).
• Thorough knowledge of cGMP, FDA and Data Integrity regulations.
• Experience with computerized system validation methodologies, 21 CFR Part 11, and Data Integrity regulations.
• Minimum of four (4) years of computerized system validation and data integrity experience within pharmaceutical manufacturing operations.
• Proven experience supporting laboratory, sterile and non-sterile operations.
• Proven skills in project management.
• Ability to impact and influence people and areas within the company to deliver superior business results.
• Excellent communication skills (oral, written and reading) in Spanish and English.

Skills

cGMP knowledge

FDA regulations

Data Integrity

CV/Validation

Project management

Bilingual English/Spanish

Education

Bachelor's Degree in Science

Job description

The resources for this opportunity must meet the following minimum requirements in order to be considered:

Qualifications and Required Knowledge/Skills

• Bachelor’s Degree in Science (Computer Systems or Engineering preferred).
• Thorough knowledge of cGMP, FDA and Data Integrity regulations is a must.
• Experience with computerized system validation methodologies, 21 CFR Part 11, and Data Integrity regulations.
• Minimum of four (4) years of computerized system validation and data integrity experience within pharmaceutical manufacturing operations.
• Proven experience supporting laboratory, sterile and non-sterile operations.
• Proven skills in project management.
• Ability to impact and influence people and areas within the company to deliver superior business results.
• Excellent communication skills (oral, written and reading) in Spanish and English.

Weil Group is proud to be an Equal Employment Opportunity Employer.