Freelance CSV Consultant

For the past 20 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. As the world’s largest RCO (Research Consulting Organization), 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 description

We are currently searching for an independent CSV Engineer ideally with DI experience to assume a new project we have on a freelance basis. This project will last approximately for 12 month; it will ideally commence as of the 1st July and is for 1.0 FTE (approx. 40 hours per week). This role can be performed on a Hybrid basis (2 weeks remote, 1 week onsite in Ireland) with the initial period being more onsite why the project commences.

Essential Functions Include :

Participate and lead CSV activities linked to DI projects

Provide guidance to computer system validation and data integrity compliance approaches.

Independently and participate with larger teams of resources in delivery of CSV and Data Integrity projects.

Provide CSV services which could include e.g., authoring CSV deliverables such as Validation Plans, Requirements, Risk Assessments, IQs, OQs, PQs, Trace Matrices, and Validation Reports.

Act as the SME within CSV as and when needed

Support key initiatives and offer concise advise on a range of topics linked within the CSV automation space

Support other on-going activities as and when needed

Qualifications

B.S. / B.A. in Engineering, Science, Information Technology or related field.

Must demonstrate skills in CSV with the life-science industries

Data Integrity experience would be highly preferred

Fluent in English

Can work on a Hybrid approach in Ireland as designated within the Job description

Available to take on a new contract in 1st July 2024 for one year

Flexible with strong stakeholder management skills

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.

• ProPharma Group does not accept unsolicited resumes from recruiters / third parties. Please, no phone calls or emails to anyone regarding this posting.