Computer Systems Validation Associate II

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization seeking a Computer Systems Validation Associate II. The successful candidate will have experience in computer systems validation, technical writing, and regulatory compliance. The position requires a strong understanding of industry best practices and the ability to communicate complex systems to technical and non-technical management.

Requirements

• BS in Electronic or Software Engineering, Information Systems, or a related field, preferred
• 3+ years experience of working within a regulated environment, particularly in computer systems validation or other validation discipline
• Ability to use enterprise software (i.e., ERP, EDMS, QMS, JDE, Trackwise, etc.)
• Experience with Microsoft Project
• Technical writing skills

Benefits

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Additional Benefits
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal