Drug Product Manufacturing Associate Alexion

The Drug Product (DP) Manufacturing Associate will be a key member in supporting the execution of operational readiness at the Alexion Athlone Manufacturing Facility. The Manufacturing Associate will be an SME in a number of unit operations throughout the Fill Finish manufacturing process and will be responsible for execution of batch operations as per standard operating procedures under limited supervision.

Responsibilities:

• Operate manufacturing equipment and instruments and complete assigned tasks in a timely manner
• Execute the production schedule / plan on a day-to-day basis to meet production forecast and the required output
• Perform daily / weekly /monthly internal calibrations and verification checks ensure all documentation is complete in a timely manner
• Provide Technical support for troubleshooting equipment and process activities
• Complete Master Batch Records (MBRs), logbook entries and any required GMP documentation to cGDP
• Prepare, review and approve MBRs, SOPs and logbooks
• Perform logbook reviews to ensure all documentation is in line with audit readiness
• Record and update production metrics
• Ensure all training is performed in full and completed in a timely manner
• Ensue all tasks performed are compliant with cGMP and EHS guidelines
• Work as a team to support, develop and encourage collaboration with all departments to work as one team on site
• Ensure all production deviations are raised with Production Supervisor / QA immediately
• Support Root Cause Analyse for all quality deviations within the production areas, complete assigned CAPA actions within the designated timeframe
• Support the creation of EHS task risk assessments within the production areas
• Report any machine issues (Downtime or Rejects) to the Team Supervisor and to the maintenance department
• Assume responsibility for the day to day housekeeping duties within the assembly area
• Routinely draft/ create and revise standard operating procedures, manufacturing batch records and other documents as required
• Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
• Embrace Alexion Core Competencies
• Aseptic Filling with RABS in grade B background
• Compounding / Formulation of products
• Sterile Filling of vials / syringes using Isolator
• Visual Inspection of finished product.
• Cleaning and Sanitation of equipment
• Operation of Parts washers and Autoclaves
• Troubleshoot and resolve operational problems during processing
• Represent Manufacturing in cross functional initiatives and meetings
• Perform Manufacturing review and approval of critical documents
• Maintain good housekeeping and clean and sanitize classified areas as required

Requirements:

• Must be able to work within and adapt to complex electronic systems such as SAP and Trackwise
• Must be able to read, write and converse in English
• Must have good working knowledge of MS Excel and Word
• Ability to work in an intense, fast-paced work environment
• Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously
• Ability to work independently and as part of a team
• More than 2 years’ experience in a cGMP biopharmaceutical manufacturing environment.
• Basic knowledge and understanding of a computer.
• Must be willing to work on a 2 shift basis - The company will operate 2 shifts 5 days, Shift will be 7am-3pm and 3pm-11pm
• Must be willing to work in a controlled cleanroom environment, which involves the wearing of a gown, cap and relevant cleanroom regimes
• BA/BS in a scientific discipline or equivalent experience preferred

Bidvest Noonan is a team of 27,000 passionate and customer-focused people. We work together to deliver exceptional service and value to customers across the UK and Ireland. We recruit great people to deliver our services and we provide them with the resources, training, and direction they need to do their best work.

We always put people first. Our people are exceptional and go the extra mile to deliver outstanding services. We celebrate and recognise their successes at every opportunity. At Bidvest Noonan, we strive to make each person feel appreciated, engaged, and supported so that they can reach their potential, knowing it has a positive impact on our overall success.

Bidvest Noonan is highly committed to creating an inclusive environment where everyone can feel valued and respected. We are delighted to welcome applicants from our Armed Forces community and people from diverse backgrounds and identities.