Production Technician
We have an exciting opportunity for a Production Technician to work for our global pharmaceutical client based in Milton Keynes. The role is a full-time temporary contract initially signed off for 12 months with a possible extension and offers an hourly rate of £14.00 - £16.00 per hour, depending on experience. You will be required to work 37.5 hours per week (Monday - Friday).
The successful candidate will operate and maintain live virus vaccine equipment as part of an empowered work team. Routinely perform line- specific duties including line check-in in-process quality monitoring, equipment operation, work center cleaning and change-over. Position will receive direction and support.
Reporting to the Lead Technician the Production Technician is responsible for:
*Perform Direct associated with the manufacture of intermediates (media & antigen) per the Production Schedule and in accordance with local Regulatory and GMP requirements
*Prepare, stage, use and maintain a variety of mechanical or laboratory equipment.
*Follow standard operating procedures and ensure Good Documentation Practices
*Participate in Site Tier Process
*Apply MPS tools and methodology to lead and support investigations and CAPA implementation
*Participate in company sponsored training and events
*Model Safe by Choice and Inclusive Behaviors
Production Duties include:
Planning
*In consultation with the Lead Technician facilitate implementation of production plans in accordance with production schedule.
Stock Control
*Monitor and Maintain inventory stock and participate in returns process.
*Participate in routine Cycle Counts as per procedure and including annual Stocktake.
Records and Reconciliation
*Maintain concurrent records including manufacturing directions, log sheets, and all other pertinent documents in line with local procedures and the Code of GMP.
*Review and verify product batch records for accuracy of entries, compliance to established limits, specifications and the presence of all verification signatures.
Production
*Understand and follow Standard Operating Procedures (SOP) and Batch Manufacturing Instructions (BMI)
*Participate in direct activities associated with media and intermediate manufacture
*Prepare, sterilize and stage Laboratory consumables required for manufacturing
*Prepare stage and use machinery or laboratory equipment necessary to perform manufacturing.
*Check Equipment is Fit for Purpose prior to use. Perform routine operational cleaning and maintenance to maintain equipment in compliant state
*Operate equipment as per site documentation or manufacturer’s instructions and for intended use only
*Identify equipment which requires repair or replacement
*Work in a clean, aseptic environment (cleanroom environment).
*Able to undertake periods of work with Manual handling and lifting
*Responsible for Good housekeeping in the work area in accordance with company and relevant quality standards.
*Complete SAP transactions relevant to manufacture within company specified timeframes
*Raise purchase requisitions of operating supplies and recommend purchase of new or replacement equipment.
*Collaborate with other Departments as required
*Basic Mechanical aptitude
Reporting and Delegation
*Participate in routine reporting as required.
*Identify and assign delegation of activities during periods of offsite work, leave or where contact is expected to be difficult. Delegation should be communicated to Senior Technician, Operational Coach and relevant Tier Streams
Compliance Duties:
Tier Process
*Participate in the Department Tier 1 meetings and escalate any impacts on schedule to Tier 2.
*Participate in other identified cross stream Tier meetings as required.
Issue Management and Escalation
*Notify and, escalate any issues which may impact on the Production Scheduled to the Lead Technician and Operational Coach or delegate.
*Support department or Cross functional investigations and CAPA Activity
Documentation
*Complete and maintain all documentation in accordance with company and relevant quality standards. Support on time adherence to the Documentation Work Plan by participating in MIDAS update process.
*Ensure compliance with local documentation requirements
*Participate in on- the-job training
Quality Manual Sub Chapters
Support activities required to adhere to AHQM sub chapters associated with Manufacturing
Environment Health & Safety
*Participate in Safe by Choice Discussions within Department Tier 1
*Model Safe by Choice and Inclusive behaviours within Production and across broader business
*Co-operate with Management with respect to any action taken to comply with the EHS requirements
*Proactively contribute to Hazard and Near Miss identification, Incident Investigation and corrective and preventative action
Required Experience and Skills:
*Strong verbal and written communication skills
*Basic Math aptitude
*Strong work ethic
*Attention to detail
*Ability to follow approved documentation practices
*1-2 years relevant experience working in a production laboratory
*Ability to work in a team environment
*Basic computer skills (Word/Outlook/Excel)
*Follow Good Manufacturing Practices and Standard Operating Procedures
Preferred Experience and Skills:
*2-3 years relevant manufacturing experience and a basic understanding of manufacturing procedures, techniques and equipment
*Working knowledge of cGMP and inventory control concepts (strongly preferred).
*Understanding of aseptic techniques and procedures.
*College degree in a relevant scientific field (biology / chemistry, life science) (optional).
*Experience in large scale bacterial antigen processing.
*Working knowledge of fermentation and fermentation vessels
*Experience using SAP
Education Minimum Requirement:
A-levels in Science based subjects