John Hellin Email & Phone Number

Adelaide, South Australia, Australia

Adelaide, South Australia, Australia

Auckland, New Zealand

Auckland, New Zealand

Balcatta, Western Australia

• Maintenance of facilities, utilities and equipment at WA production site • Successfully project managed a $1M investment for a vacuum processing plant from concept, through design, to installation and commissioning, integrating into existing utilities with significant facility modifications, delivered within budget• Ensuring strict compliance with relevant statutory requirements• Utility efficiency monitoring, contingency planning and disaster recovery• Planning and execution of preventative maintenance program, managing site maintenance budget • Identifying and managing capital projects for equipment, major upgrades and facility modifications• Controlling consumables and critical spares inventory, overseeing workshop, issuing high risk work permits• Managing all 3rd party contract agreements and maintaining contractor relationships

Balcatta, Western Australia

• Seconded as Project Manager during $6.5M facility expansion• Oversight of new building, major utilities upgrades• Installation of process vessels, equipment and piping with associated control systems for filling line delivery and automated CIP• Responsible for planning and reviewing schedules for specific work packages with stakeholders• Selection and procurement of equipment and materials• Negotiation of contracts and managing expenditure• Risk assessment and change control analysis• Assessed workmanship and collating associated project documentation and reports

Balcatta, Western Australia

• Supervised production floor and coordination of all manufacturing, packaging and cleaning • Liaised with departmental managers to ensure production plan achieved• Data analysis of production efficiencies and downtime including trending • Identified the need for and implementation of new equipment• Wrote Standard Operating Procedures for new and existing production equipment and processes• Trained production personnel in current SOP’s, GMP and safe working practices• Managed staff roster and recruited of new production personnel • Successful implementation of new packaging line resulting in major increase in production efficiencies and available capacities

Balcatta, Western Australia

• Process Variance Investigation including impact assessment, identifying practical and effective corrective and preventative actions, logging and trending of data for presentation to the Quality Management Team• Assisted product and process change control process• Audits of internal & vendor processes, testing laboratories and contract manufacturers to ensure regulatory requirements were satisfied, including establishing GMP agreements• Assisted QA Manager in product release & staff training in processing techniques• Reviewed documentation: Standard Operating Procedures, manufacturing and packaging records

Balcatta, Western Australia

• Successfully validated newly acquired manufacturing facility and executed off-site validation projects• Designed and executed validation protocols and test methods for new and existing facilities, utilities and equipment, including periodic re-validation• Conducted validation on manufacturing, packaging, sterilisation and shipping processes• Wrote Standard Operating Procedures for new equipment for hand over to system owner, training operational staff• Established and maintained contract agreements for critical calibrated instrumentation on site• Conducted physical and microbial environmental monitoring site-wide, investigating failures

Manchester, United Kingdom

Ultrafine was a R&D and custom synthesis pharmaceutical company in the UK (subsequently acquired by Sigma Global).• Responsible for custom synthesis projects’ batch sheets and contractors and suppliers relationships• Ran large scale reactions under GMP conditions, including purification, separation and evaporation techniques and managed disposal of hazardous and toxic waste

High Peak, United Kingdom

• Technical support for 24 hour bleaching plan, testing absorbency, UV, residual solvents and sulphated ash of raw and processed cotton fibre, ensuring compliance with customer specifications and pharmacopoeia

Diploma Of Project Management

Certificate Iv In Competitive Manufacturing

Education record