For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Job Summary:
The Computer Systems Validation Engineer position is responsible for authoring, executing, reviewing, and reporting on validation-related deliverables in compliance with applicable regulations and company policies and procedures.
Essential Functions:
- Develop, execute, and review complete sets of system qualification project deliverables including but not limited to requirements, plans, assessments (vendor, compliance, risk, etc.), specifications, development testing, protocols (e.g., IQ / OQ / PQ), reports, analyze test data, generate test issues, and verify test protocol execution/reports.
- Assist in the developing / review of SOPs for user operation, system administration and maintenance, back-up / recovery, and audit trail review, or other supporting process control topics within the SDLC.
- Contribute as needed in the creation, execution, and closure of QMS processes including but not limited to Change Control Projects, Deviations, CAPAs, and Quality Events.
- Contribute as needed in system periodic reviews.
- Assist in the support of audits by gathering and preparing evidence.
- Other duties as assigned.
Necessary Skills and Abilities:
- Demonstrate qualified working knowledge of all applicable consensus standard and regulatory requirements as they relate to CSV and data integrity including but not limited to the following: 21 CFR Part 11, Annex 11, ICH (E6, E9, Q9), ISO 27001 / 27002.
- Demonstrate qualified working knowledge of all applicable current industry best practice guide approaches as they relate to CSV and data integrity including but not limited to the following: FDA (CSA, DI, General Principles of Software Validation), GAMP (DI, GCP CSV, IT Infrastructure, Risk-based CSV, and Operation).
- Demonstrate qualified working knowledge of the layers of information technology / network architecture as they relate to systems and business processes (e.g., network environment, server hardware, operating systems, databases, applications, clients (endpoints); as they associate with the OSI Model and ANSI/ISA-95.
- Demonstrate qualified working knowledge of the layers of the SaaS technology stack paradigm including but not limited to IaaS, PaaS, and SaaS, their applicable components, and interrelatedness associated with a shared responsibility model.
- Demonstrate qualified working knowledge of business applications including but not limited to Adobe, DocuSign, eQMS, Global Service Desk, Microsoft Word, Microsoft Excel, and other office programs as may be required by the position e.g., including but not limited to Outlook, PowerPoint, Access / SQL, Microsoft Project, and Visio
Requirements:
- B.S. / B.A. in Engineering, Science, Information Technology, or related field.
- Candidates must have valid work authorization to work full-time in the applicable location. This position does not offer visa sponsorship.”
- Minimum 1 years of experience in the field of Computer System Validation.
- Minimum 1 years of experience in the field of IT infrastructure and systems.
- Minimum 1 years of experience in related Pharmaceutical, Biopharmaceutical, Medical Device or Healthcare Industries.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
