Fill-Finish Subject Matter Expert
Fill-Finish Subject Matter Expert
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
FillFinish Subject Matter Expert (SME)
Job Location: Beloit Wisconsin Day 1 Onsite (Candidate needs to work 4 Days at the Client Office)
seeking an experienced FillFinish Subject Matter Expert (SME) to support the commissioning and startup of a new GMPcompliant fillfinish facility for radiopharmaceutical products. This role will be critical in ensuring that the facility and operations meet regulatory standards and are prepared for fullscale production of sterile injectable products. The ideal candidate will have a strong background in GMP manufacturing sterile processing and regulatory compliance within the pharmaceutical or radiopharmaceutical industry.
Key Responsibilities
Facility Preparation & Commissioning:
o Serve as the technical expert in the design commissioning and qualification of the fillfinish facility and equipment.
o Collaborate with engineering and validation teams to ensure compliance with GMP FDA and other global regulatory standards.
o Support the qualification and validation of clean rooms HVAC systems and sterile equipment.
Process Development & Optimization:
o Consult on development scaleup and optimization of fillfinish processes for radiopharmaceuticals including aseptic filling capping sealing and inspection.
o Establish and optimize standard operating procedures (SOPs) for fillfinish processes in line with GMP requirements.
o Support troubleshooting and continuous improvement initiatives for manufacturing processes.
GMP Compliance & Documentation:
o Ensure all fillfinish operations meet GMP guidelines and regulatory standards (e.g. FDA EMA ICH).
o Develop and review batch records validation protocols and reports for all fillfinish activities.
o Lead the preparation for GMP audits and inspections working closely with the Quality Assurance (QA) team.
CrossFunctional Collaboration:
o Collaborate with R&D Engineering Validation Quality and Regulatory Affairs teams to ensure the seamless transition from facility buildout to production readiness.
o Interface with external vendors and suppliers for equipment procurement validation and ongoing maintenance.
Skillsets Required
Bachelors degree in Engineering Life Sciences Pharmacy or related field. Advanced degree preferred.
Minimum of 8 years of experience in fillfinish operations within a GMPregulated pharmaceutical or biopharmaceutical environment with a focus on sterile injectables or radiopharmaceuticals.
Proven experience in facility commissioning process validation and technology transfer in a GMP environment.
Strong knowledge of regulatory guidelines (FDA EMA ICH) and aseptic processing requirements.
Excellent problemsolving project management and communication skills.
Ability to work crossfunctionally and lead teams in a highly regulated environment.
Experience with radiopharmaceutical products.
Knowledge of cGMPs for the production of sterile pharmaceuticals and radiopharmaceuticals.
Experience with quality systems risk management and regulatory submissions.
Employment Type
Full Time
