Computer Systems Validation Specialist

Description:The Computer Systems Validation Specialist is responsible for the installation, configuration, and validation of the corporate software and hardware systems which may include standard application servers as well as laboratory and manufacturing systems. The incumbent must be able to efficiently analyze the corporate systems to be installed or upgraded to ensure that FDA regulations and the industry best practices are adhered to. The ability to quickly assess a need, propose/lead a project, draft required validation documentation, and implement with minimal supervision is required.

• Follow necessary SOPs pertaining to installation, support and use of validated software and hardware.
• Initiate required documentation workflows for validated software and hardware changes.
• Create, review, and update IT related GMP documents.
• Work with partner entities as needed to implement, support, and maintain the validated hardware and software systems.
• Work within multi-disciplinary teams to complete projects within the scopes defined.
• Communicate project status to Management and outside qualified vendors and consultants as necessary.
• Effectively support other IT functions as needed, such as Help Desk support.

Requirements:

• Minimum 10 years experience in hardware and software administration and troubleshooting.
• Minimum 5 years experience validating IT related hardware and software.
• Must be able to work independently and successfully manage projects to completion, with strong written and verbal communication skills.
• Must have software and hardware validation experience pertaining to FDA and GMP regulations.
• Must have experience designing, configuring, validating, implementing and supporting enterprise level systems.
• Pharmaceutical industry experience a plus (Validation, SOP, GMP, Change Control).
• ERP implementation or administration helpful.
• Bachelor's degree in Computer Science preferred; industry experience will be considered.
• Technical Certification(s) (i.e. MCITP, MCSE, MCAA, CCNA) preferred.
• This position requires a pre-employment drug screen/ physical and background checks.

EO Employer M/F/Vets/Disabled
E-verify Participant.

Job Type: Full-time

Pay: $95,000.00 - $105,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Work Location: In person