Mutiple Process Engineers

Sterile experience preferred
Jenn Dinan at Wallace Myers is recruiting Multiple Process Engineers to work on contract at our Global Biopharma client's site in Waterford. Contact Jenn Dinan on or email

Job Purpose

Provide leadership and support to operations teams to ensure appropriate standards are met. Development and implementation of improvement initiatives in all manufacturing and development operations.

Job Requirements

• Optimisation of manufacturing and development operations
• Identification & implementation of opportunities for improvements
• Assist in the implementation of capital projects
• Act as process lead for inspection development
• Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams.
• Implementation and monitoring of performance metrics
• Lead cycle time reduction initiatives in conjunction with manufacturing teams
• Implementation of best practice
• Process development programme design / plant trials, execution and implementation
• Constantly seeking to challenge operational standards and driving continuous improvement.
• Ability to multitask and prioritize workload
• Maintain required quality documents in a current compliant state.
• Subject Matter Expert for and team resource for new product introductions / enhancement development projects
• Resource for Clinical supply provision projects
• Aseptic manufacture or oral dose manufacture context
• Subject Matter Expert for product quality attributes and process critical parameters
• Design and execution of experimental programmes
• Operation of process laboratories
• Scale-up and technology transfer project role
• Liaison for Clinical supply provision projects
• Liaison for New formulation and product enhancement programmes
• Complaints, LCRs, Deviations, CAPAs support ensuring effective RCA Smart CAPA's and on time closure
• Attainment of SMART goals.
• Reduction in process cycle-times.
• Ensure compliance to cGMP at all times

Qualifications

• Degree in Chemical, Industrial or equivalent Engineering discipline
• Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage

Skills & Knowledge

• Technical knowledge(theory and practice) of aseptic manufacturing including lyophilisation considered an advantage
• Design of Experiment and associated statistical techniques Pharmaceutical product development project life-cycle
• Strong report-writing and verbal communication skills
• Laboratory and pilot plant skills
• Innovation and creativity skills
• Structured Problem-solving skills - Statistical