Fill Finish Subject Matter Expert (SME)

TN United Kingdom; Birmingham; Hybrid; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Fill Finish Subject Matter Expert to provide technical leadership within the pharmaceutical sector. This hybrid role offers the opportunity to engage with global networks, mentor upcoming experts, and participate in key project phases from planning to execution. With a focus on facility operations, regulatory frameworks, and industry technologies, this position is ideal for seasoned professionals looking to make a significant impact in a dynamic environment. If you are passionate about driving innovation and excellence in pharmaceutical processes, this role is for you.

Qualifications

• 15+ years of experience in design, operations, or process development.
• Strong knowledge of industry technologies and regulatory frameworks.

Responsibilities

• Lead technical expertise in Fill Finish and promote knowledge exchange.
• Support project teams technically and conduct peer reviews.

Skills

Technical Leadership

Communication Skills

Problem-Solving

Client Interfacing

Education

Bachelor's Degree

Master's Degree

Job description

Job Description: Fill Finish Subject Matter Expert (SME), Birmingham

This role involves providing technical leadership as a Subject Matter Expert in Fill Finish within the pharmaceutical industry. The SME will be part of a global group, working in a hybrid model with potential travel to project sites. The position can be based in Ireland, UK, Belgium, The Netherlands, or Poland.

Responsibilities include:

1. Leading technical expertise in nominated areas, staying current with industry developments, and promoting knowledge exchange.
2. Acting as SME during early project phases, including site planning, feasibility, and design, producing and reviewing key project deliverables.
3. Supporting project teams technically and conducting peer reviews.
4. Engaging with global SME networks and mentoring upcoming experts.
5. Participating in technical design reviews, R&D activities, and business development efforts.
6. Traveling as needed for project meetings and workshops.

Knowledge areas covered:

• Facility layout principles, including area classifications and adjacencies.
• Unit operations and technologies such as parenterals, sterilization, filling, lyophilization, and inspection.
• Equipment expertise, including filling, closing, isolators, and sterilizers.
• Facility operations, GMP, regulatory frameworks, and project delivery aspects.

Qualifications:

• Bachelor's degree required; Master's preferred.
• 15+ years of experience in design, operations, or process development.
• Industry engagement with institutions like ISPE.
• Strong knowledge of industry technologies, regulatory frameworks, and facility design principles.
• Excellent communication, problem-solving, and client interfacing skills.