Freelance/Contract Process Validation Consultant - Filling lines

Company profile

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

At present, we are currently looking for a “Freelance/Contract Process Validation Engineer – Filling lines (bowls/stoppers)” to support one of our Life-science clients for a short term project assessing their filling lines (Handling of bowls for stoppers). This project is to support the evaluation of the current method designed for filling lines and requires approx. 20-30 hours support and will be concluded with a presentation to the client. This project is to commence immediately and can be performed fully remotely (will run for 2-3 weeks from start to finish).

Responsibilities included:

• They require support on EU GMP Annex 1 with a focus on sterile handling of bowls for stoppers and cast parts.
• Current practice is to clean, decontaminate & install bowl where the proposed method change would be to install equipment first, then decontaminate, with everything sterile during mounting (Full evaluation required on this aspect plus presentation).
• Provide regulatory alignment and practical recommendations.
• Identify risks, gaps, and best practices for sterile assembly of stopper bowls and related equipment.

Skills required

• Must be educated within a life science or engineering discipline to at least a BSc or higher
• Proven experience working in Validation with Stoppers within aseptic environment (Pharmaceutical or Biotechnology only)
• Substantial experience in filling line activities is a must
• Fluent in English
• Substantial experience in filling line activities is a must
• Fluent in English
• Can commence immediately and present findings within 2 weeks of start date

Additional Information

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.***