Computer Systems Validation Consultant

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.

This full-time, permanent Computer Systems Validation Consultant position is responsible for independently managing Computer System
Validation projects and providing consulting and contract services to clients. The consultant will support computer system validation activities
focusing primarily on authoring validation documents, verification test execution. and technical writing.

Essential Functions Include:

• Author Validation Plans and Test Plans
• Author User and Functional Requirements Specifications
• Author qualification protocols (IQ/OQ/PQ) and associated Trace Matrices
• Execute qualification protocols (IQ/OQ/PQ), collect testing evidence and document deviations.
• Author Part 11 and Annex 11 Compliance Reports
• Author Test Reports and Validation Reports
• Perform technical writing and communicate clearly on all technical, business, and professional interpersonal levels of the organization.
• Apply Computer System Validation experience as it relates to GxP regulated business processes.
• Attend and contribute to scheduled CSV Practice meetings.
• Participate in company programs such as Project Management, Quality, Social Responsibility, Wellness, Safety, and Training.
• Obtain specific assignments from ProPharma Group or the client Project Manager.
• Ensure individual activities are communicated and documented to the Project Manager.
• Create annual personal goals and development plans with administrative manager.
• Assist with interviews of ProPharma Group candidates.
• Other duties as assigned.

Qualifications

Qualified candidates must have:

• B.S./B.A. in Engineering, Science, Information Technology, or related field.
• Three years of relevant work experience may be substituted in lieu of education in the specific fields listed above.
• Minimum 3 years experience in the field of Computer System Validation.
• Minimum 3 years experience in related Pharmaceutical or Healthcare Industries.
• Experience in the validation of at least two of the following computer system categories: clinical data/study management, automation control, laboratory systems, quality management systems, ERP, and medical device software.
• Must be able to quickly learn new software applications used in GxP activities.
• Possess effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
• Working knowledge of Microsoft Word and Microsoft Excel. Other programs as may be required by the position, e.g., PowerPoint, Access, Microsoft Project, Visio.
• Must be able to work with client systems and equipment; analyze data for development of reports; assemble documentation as required.
• Basic knowledge of FDA GxPs, FDA Guidelines, and European Guidelines and other regulatory requirements.
• Basic knowledge of industry best practice such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
• Basic knowledge of 21 CFR 11, including ERES, predicate rule and legacy system requirements.

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.***