Full Job Description
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position
Qualifications:
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. Senior CSV Specialist (Back-Fill) - RFP Position Description | Page 3 BMS Confidential
• 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.
Working Conditions Work Environment: Normal office environment and laboratory working environment. The role may involve exposure to potentially toxic materials used in analysis, due to the need to visit laboratory areas during qualification and validation studies. Travel: 10% to 15%, to participate in the design, planning, implementation and follow-up of quality computerized systems projects and/or Enterprise IT Solutions.
Shifts: Must be available to work rotating shifts, irregular hours, weekends and holidays, depending on operational needs.
