🌎
This job posting isn't available in all website languages

Process Development Associate 4

📁
Manufacturing Operations
📅
3525 Total Views
Apply for Job
Recommend to a Friend
Sign Up for Job Alerts
JOB SUMMARY
 

As a Process Development Associate IV, they will ensure manufacturing processes are successfully transferred from R&D to Manufacturing. This is applied through the application of technical expertise in leading process validation to the manufacturing processes implemented on site. Another key element to this role is to continuously identify and lead the delivery pf improvements throughout the operation that develop lean manufacturing processes and have a positive effect on the business unit’s budget and profitability.

 
ROLE ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Leads process transfer projects, including organising meetings, setting clear agendas, taking effective meeting minutes and assigning actions
  • Ensures blockers to the Process timeline are addressed and escalated where required and hold individuals accountable for outstanding project actions.
  • Establishes project timelines and milestones, with use of Microsoft Project, and communicate out to the Project Team
  • Leads the execution process validation of new and existing manufacturing processes
  • Writes validation protocols and reports detailing clear aims and objectives and the required acceptance criteria.
  • Leads and executes process risk assessments using tools such as Failure Mode and Effects Analysis (FMEA) associated documentation requirements
  • Leads and executes validation risk assessments to ensure the necessary validation controls are identified and in place before validation execution
  • Attend regular communication meetings with cross-functional teams to report on project progress
  • Organises project meetings to ensure improvement project actions are outlined and provides a forum to update on the status of these actions
  • Responsible for training Process Transfer operators where required.
  • Represents Process Transfer on one or more core teams
  • Revises a variety of lifecycle documents. Document types include but are not limited to; master validation plans and reports, SOPs, work instructions and forms, CAPAs, CORs and deviations.
  • Revises documentation associated with function to ensure compliance with procedures and applicable regulatory requirements
  • Supports manufacturing operations by establishing and implementing process improvements
  • Acts as subject matter expert (SME) during internal and external audits, where required
  • Produces notebook materials per written instructions
  • Ensures material inventories and ensuring ERP transactions are completed

 YOUR KNOWLEDGE, EDUCATION AND EXPERIENCE

  •      Must be proficient in the knowledge of applicable Quality System Regulations and ISO-13485 quality requirements

  • Proficient in a variety of validation methods and evaluation criteria, in particular process validation
  • Proficient in spreadsheets and word processor applications
  • Proficient in concepts of statistics, sampling plans and statistical analysis, preferably with the ability to use Minitab software or applicable
  • Ability to independently plan, execute, and/or problem solve moderate to complex situations
  • Solid oral and written communication skills
  • Ability to manage multiple projects and lead projects to the agreed timeline, with the use of Microsoft Project and Prince 2 principles or applicable
  • Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation
  • Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc. effectively

Previous Job Searches

Similar Listings

Manchester, Wythenshawe, United Kingdom

📁 Manufacturing Operations

Manchester, Wythenshawe, United Kingdom

📁 Manufacturing Operations

Manchester, Wythenshawe, United Kingdom

📁 Manufacturing Operations