About the Role
- Support a dynamic maintenance team with a high safety orientated Culture, in cGMP compliant work environment at all times.
- You will be part of a multiskilled maintenance team responsible for front line maintenance across the Drug Substance building. Supporting the Area Process Centric Teams (PCT).
- Responsible for completion of all maintenance tasks according to relevant SOPs.
- Complete all maintenance Planned routines assigned to Drug Substance Engineering teams and oversee the completion of maintenance routines by third party suppliers.
- Integrate with your PCT team members within both the engineering and manufacturing organizations to help develop and support area Total Productive Maintenance (TPM) process.
- Perform detail troubleshooting of issues identified during routine operations.
- Assist with the investigation of and operations deviations through Quality System, engaging with all relevant personnel and functions as appropriate.
- Seek opportunities for Continuous Improvement through the use of Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.)
- Where necessary assist in any in Facility and Equipment start up and Validation activities. Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.
- Capable of working with individuals and with a team of up to 24 people
- Electrical or Mechanical trade qualification or equivalent Diploma/Degree is essential.
- Minimum 3 years’ experience in a biopharmaceutical or pharmaceutical cGMP manufacturing.
- Experience executing Engineering tasks using Engineering maintenance management systems including EAMs.
- Experience to include activities such as Clean in Place/Steam in Place Systems, Washers, Autoclaves, Large Bio reactors/ Buffer vessels, Conjugation, Column Packing, Ultrafiltration/Diafiltration, Chromatography and Sterile Filtration
- Experience in troubleshooting equipment and/or processing issues during startup and cGMP production within Grade C/D manufacturing areas.
- Experience with use of Lean Tools such as Standard Work/5S and Six Sigma Tools such as Method 1 and 5 Whys
- Excellent interpersonal skills, positive influence, team orientation, attention to detail, documentation skills, problem identification and problem solving skills.