Computer Systems Validation Specialist

Company: POINT Biopharma
Location: Indianapolis
Posted on: November 26, 2022

Job Description:

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.Location: Indianapolis, IN Reporting to the Senior Director, Quality Assurance/Quality Control, the Computer Systems Validation Specialist is responsible for implementing FDA 21 CFR Part 11 compliance across electronic systems within a GMP production facility. Accountabilities

• Qualify/validate all computer systems which impact cGMP operations using a risk-based methodology
• Develop/write CFR Part 11-compliant computer systems validation plans, qualifications test protocols (IQ/OQ/PQ), user requirements, traceability matrices, reports, and all documents, and deliverables within the scope of the validation plan
• Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
• Act as a CSV Lead for all validation projects, including spreadsheet and quality system validations
• Create/maintain/follow procedures related to Data Integrity and software validation, and lead 21 CFR Part 11 related training to all departments
• Maintain cGMP compliance and serve as the subject matter expert during regulatory audits
• Execute or oversee the execution of validation plans and validation documents
• Provide guidance in the proper execution of validation documents
• Evaluate proposed changes to validated computer systems and recommend level of revalidation activities required
• Coordinate and perform audits of internal computer systems, validation activities, protocols and procedures, and prepare responses
• Complete corrective actions/preventative actions (CAPAs) pertaining to CSV
• Review standards/regulation updates and perform gap assessments
• Perform project management activities for CSV processes within the scope of an overall system project
• Work with overall project manager to include validation activities in implementation timelines
• Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents
• Work closely with Quality Assurance, Facilities and Engineering Teams to ensure appropriate validation of cGMP computer systems Requirements
  • Minimum of 8 years of Computer Software Validation experience in a GMP pharmaceutical or medical device environment or 4 years of experience with an Associate Degree in computer science, life science, or engineering.
  • Experience in the review, evaluation and testing of systems to ensure compliance with the FDA/Eudralex Electronic Records/Electronic Signatures regulation and 21 CFR/Annex 11 EU-GMP
  • Experience writing/executing software validation documents and delivering 21 CFR Part 11 related training to cross-functional departments
  • Experience with Building Management Systems, Environmental Monitoring Systems, laboratory equipment, GMP requirements, and commissioning and qualification practices in a pharmaceutical environment
  • Strong computer, communication, and interpersonal skills
  • Experience in new installation projects, including QC systems and manufacturing lines is an asset
  • Experience in change control evaluation and CAPA management is an asset Why joining POINT today will be the right career move for you: There is no shortage of demand for smart, qualified and hardworking people like yourself - and we strongly believe POINT is the right career move for you. Here is why:
    • You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
    • You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
    • You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
    • Most importantly, you will spend everyday working on something important If what we are saying resonates with you, please submit a resume.Benefits
      • Health Care Plan (Medical, Dental & Vision) - effective day 1
      • Retirement Plan (401k - up to 2% match with immediate vest)
      • Income Protection Insurance - (Life AD&D, Short & Long-term disability) - 100% employer paid
      • Voluntary Income Protection - Premiums paid by employee
      • Paid Time Off (Vacation, Sick & Public Holidays)
      • $500 fitness reimbursement per year
      • $50 cell phone reimbursement per pay cycle All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law. POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Keywords: POINT Biopharma, Indianapolis , Computer Systems Validation Specialist, IT / Software / Systems , Indianapolis, Indiana