Freelance CSV Consultant

TN Ireland; Ireland; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

An established industry player is seeking an independent CSV Engineer with expertise in Data Integrity for a new project. This exciting freelance role offers the opportunity to lead and participate in CSV activities linked to data integrity projects. You will work closely with teams to deliver crucial CSV services, authoring essential validation documents, and providing guidance on compliance. The position allows for a hybrid work approach, combining onsite and remote work in Ireland. If you are passionate about contributing to high-profile projects in the life sciences sector, this is the perfect opportunity for you.

Qualifications

• Experience in CSV with life-science industries is essential.
• Data Integrity experience is highly preferred.

Responsibilities

• Lead CSV activities linked to DI projects and author validation deliverables.
• Provide guidance on compliance approaches and support key initiatives.

Skills

Computer System Validation (CSV)

Data Integrity

Stakeholder Management

Education

B.S./B.A. in Engineering

B.S./B.A. in Science

B.S./B.A. in Information Technology

Tools

Validation Plans

Risk Assessments

Trace Matrices

Job description

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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.

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 months; 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 while the project commences.

Essential Functions Include:

1. Participate and lead CSV activities linked to DI projects.
2. Provide guidance to computer system validation and data integrity compliance approaches.
3. Independently and participate with larger teams of resources in delivery of CSV and Data Integrity projects.
4. 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.
5. Act as the SME within CSV as and when needed.
6. Support key initiatives and offer concise advice on a range of topics linked within the CSV automation space.
7. Support other ongoing activities as and when needed.

Qualifications

1. B.S./B.A. in Engineering, Science, Information Technology or related field.
2. Must demonstrate skills in CSV with the life-science industries.
3. Data Integrity experience would be highly preferred.
4. Can work on a Hybrid approach in Ireland as designated within the Job description.
5. Available to take on a new contract on 1st July 2024 for one year.
6. 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.