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Computer Systems Validation (CSV)

Alliance Biotech Solutions
Raleigh, NC Full Time
POSTED ON 4/8/2024

Alliance Biotech Solutions (ABS) is a quality partner providing first in class solutions to the biotech and life sciences industries.  While our offerings are limitless, we are focused on providing Engineering, Qualification, and Compliance solutions for our clients.  ABS employees are our product for the industry, and therefore our #1 priority because without them ABS cannot exist.  They strengthen us in everything we do.  We recognize their value as contributors (individual and/or teams) for our partners.  Encouraging growth and stretching their potential is paramount to success, and achievements for all.

Position Responsibilities

  • Must be able to work independently, in a team environment, or leading a small team while interacting with individuals at all levels in an organization, teams, and departments
  • Strong understanding of common Qualification documentation and practices including, but not limited to Standard Operating Procedures (SOP’s), User Requirements Specifications (URS), Risk Assessments (RA), Functional Specifications (FS), Software Design Specification (SDS), Hardware Design Specification (HDS), and Data Integrity Assessment (DIA)
  • Writing and executing, Installation Operational Qualification (IOQ) protocols and Summary Reports including thorough resolution of protocol deviations
  • Expected to interface with clients and establish solid working relationships
  • Ability to work on multiple projects simultaneously and coordinate execution and projects
  • Ability to work in a client facing role and interact with key stake holders to coordinate and communicate as required to support your assigned deliverables

Experience

  • Experience performing CSV activities in an cGMP environment, along with different environments (development, production, training, etc)
  • Familiarity with IT infrastructure including but not limited to, networking, storage, and archival components.
  • Experience with Disturbed Control Systems (DCS) or IT supported applications
  • Familiarity with PLC, HMI, Scada, DCS and BMS systems is a plus
  • Maintaining an up-to-date knowledge of validation requirements, practices, and procedures including an understanding of ICH, GxP, GAMP5, cGMP, CFRs (Part 11, 210, and 211), FDA/EU regulatory requirements and associated guidance documents

Skills and Abilities
Excellent technical problem-solving and troubleshooting skills
High attention to detail
Exceptional interpersonal and organizational skills.
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Willing and able to thrive in unusually fast paced and changing environments
Ability to work independently, while supporting other team members
Ability to change priorities in response to company demands while continuing to deliver results

Benefits
Industry competitive wage as a full-time employee
Flexible Paid Time Off
Bonus plans
Medical, Dental and Vision Insurance with low employee cost
Employer paid long term and short-term disability
401k plan with employer contributions

Alliance Biotech Solutions is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee.

All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Salary.com Estimation for Computer Systems Validation (CSV) in Raleigh, NC
$96,982 to $121,372
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