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 centre 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