Mutiple Process Engineers

Wallace Myers International; Waterford; On-site; EUR 60,000 - 90,000; Full time

Job summary

Wallace Myers International is recruiting Multiple Process Engineers on contract to work at our Global Biopharma client's site in Waterford. Experience in sterile processes preferred. Some shift work may be required. Immediate EU work authorization is required for these contracts.

Role involves leading operations improvements, process development, scale-up, and transfer, with a focus on aseptic manufacturing and quality compliance in a regulated biopharma environment.

Qualifications

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

Responsibilities

• Provide leadership and support to operations teams to ensure standards are met.
• Develop and implement improvement initiatives in manufacturing and development operations.
• Lead technical problem resolution and RCA for manufacturing operations with cross-functional teams.
• Implement and monitor performance metrics and cycle time reduction initiatives.
• Act as SME for new product introductions, process development, scale-up and tech transfer.
• Ensure cGMP compliance and maintain quality documents.

Skills

Aseptic manufacturing knowledge

Design of Experiment

Statistical techniques

Project management

Structured problem solving

Verbal communication

Report writing

Laboratory and pilot plant skills

Education

Chemical/Industrial Engineering degree

Job description

Jenn Dinan at Wallace Myers is recruiting Multiple Process Engineers to work on contract at our Global Biopharma client's site in Waterford. Sterile experience preferred. There may be some shift requirements so please make sure to highlight if you are open to working on shift. Please note: These are professional service contract positions requiring immediate EU work authorization (EU Passport or Stamp 4). We are unable to consider candidates requiring visa sponsorship or those on Stamp 1G graduate visas for these Ltd contract roles.

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

Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations 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 Research skills Innovation and creativity skills Project management skills Structured Problem-solving skills - Statistical

Process Engineer Biopharmaceutical Sterile Operations OEE TPBN1_IJ