Manufacturing Process Specialist

We are looking for a Manufacturing Process Specialist to support Pharmaceutical Operations and provide technical leadership and direction for the manufacturing department across several areas including formulation aseptic filling process isolator technology and representation at various regulatory audits. This position is based at Abbvie Sligo and reports to the Operations Manager/Lead.

Roles and Responsibilities

• On site ownership of manufacturing equipment process knowledge and technology
• Sourcing and procuring process equipment including technical oversight of procurement process.
• Provide technical support for the Manufacturing Process and Equipment Collaborate with technical groups and experts across the network ensuring consistency of technical approach and technical standards to strive for bestinclass performance.
• Design and implement technical studies and programs as appropriate to support investigations and product improvements.
• Develop knowledge of new pharmaceutical manufacturing processes as required in line with company business objectives.
• Identify and project manage continuous improvement projects. Collaborate closely with all leaders to monitor and where necessary implement improvement initiatives in line with continuous improvement philosophy.
• Continuously drive to improve processes for improved performance and cost reduction wherever possible.
• Establish/confirm specifications for process parameters process controls and equipment effectiveness.
• Establish and maintain statistical process control systems in collaboration with Manufacturing and Quality functions.
• Monitor and analyse process data during the manufacturing of drug product.
• Oversight of planning executing and reporting for all process related aspects of technology transfer projects.
• Support the introduction of new products and process to site working alongside all functions.
• Lead teams on identifying root cause and corrective actions for process deviations using best practice problem solving and continuous improvement methodologies in collaboration with other functions. Assuming accountability for risk assessments including hazards for the health and safety of company employees and visitors.
• Develop and modify procedures as needed to support the manufacturing operation.
• Participate in process equipment and facilities validations efforts and projects implementations.
• Consult with operations quality and S&T to ensure equipment and process performance is maximized.
• Adhere to all relevant policies relating to Quality & Safety.
• Ensure successful external inspections and Division and Corporate audits.
• Supervision of external contractors.

Qualifications :

• A relevant third level qualification in science engineering or technical discipline. Masters or PhD in engineering chemical or process engineering would be an advantage.
• Minimum of 3 years experience in pharmaceutical process engineering with relevant experience of batch processing technical transfers scaleup commissioning and validation in a cGMP pharmaceutical or Biologics industry
• Demonstrated project management skills including the ability to deliver projects on schedule within budget and meeting the predefined quality requirements
• Previous experience in lyophilization and sterilization operations is preferable.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No