Fill-Finish Subject Matter Expert (SME)
Apply NowCompany: InfiCare Software Technologies
Location: Beloit, WI 53511
Description:
Fill-Finish Subject Matter Expert (SME)
Job Location:- Beloit, Wisconsin- Day 1 Onsite (Candidate needs to work 4 Days at the Client Office)
Experienced Fill-Finish Subject Matter Expert (SME) to support the commissioning and start-up of a new GMP-compliant fill-finish facility for radiopharmaceutical products. This role will be critical in ensuring that the facility and operations meet regulatory standards and are prepared for full-scale 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 fill-finish 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, scale-up, and optimization of fill-finish processes for radiopharmaceuticals, including aseptic filling, capping, sealing, and inspection.
o Establish and optimize standard operating procedures (SOPs) for fill-finish processes in line with GMP requirements.
o Support troubleshooting and continuous improvement initiatives for manufacturing processes.
GMP Compliance & Documentation:
o Ensure all fill-finish operations meet GMP guidelines and regulatory standards (e.g., FDA, EMA, ICH).
o Develop and review batch records, validation protocols, and reports for all fill-finish activities.
o Lead the preparation for GMP audits and inspections, working closely with the Quality Assurance (QA) team.
Cross-Functional Collaboration:
o Collaborate with R&D, Engineering, Validation, Quality, and Regulatory Affairs teams to ensure the seamless transition from facility build-out to production readiness.
o Interface with external vendors and suppliers for equipment procurement, validation, and ongoing maintenance.
Skillsets Required
Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field. Advanced degree preferred.
Minimum of 8 years of experience in fill-finish operations within a GMP-regulated 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 problem-solving, project management, and communication skills.
Ability to work cross-functionally 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.
Job Location:- Beloit, Wisconsin- Day 1 Onsite (Candidate needs to work 4 Days at the Client Office)
Experienced Fill-Finish Subject Matter Expert (SME) to support the commissioning and start-up of a new GMP-compliant fill-finish facility for radiopharmaceutical products. This role will be critical in ensuring that the facility and operations meet regulatory standards and are prepared for full-scale 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 fill-finish 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, scale-up, and optimization of fill-finish processes for radiopharmaceuticals, including aseptic filling, capping, sealing, and inspection.
o Establish and optimize standard operating procedures (SOPs) for fill-finish processes in line with GMP requirements.
o Support troubleshooting and continuous improvement initiatives for manufacturing processes.
GMP Compliance & Documentation:
o Ensure all fill-finish operations meet GMP guidelines and regulatory standards (e.g., FDA, EMA, ICH).
o Develop and review batch records, validation protocols, and reports for all fill-finish activities.
o Lead the preparation for GMP audits and inspections, working closely with the Quality Assurance (QA) team.
Cross-Functional Collaboration:
o Collaborate with R&D, Engineering, Validation, Quality, and Regulatory Affairs teams to ensure the seamless transition from facility build-out to production readiness.
o Interface with external vendors and suppliers for equipment procurement, validation, and ongoing maintenance.
Skillsets Required
Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field. Advanced degree preferred.
Minimum of 8 years of experience in fill-finish operations within a GMP-regulated 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 problem-solving, project management, and communication skills.
Ability to work cross-functionally 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.