Career Category

Job Description

Senior Validation Engineer, Formulation & Fill Equipment

The Validation department performs equipment, utility, facility, cleaning, sterilisation and transport validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing. This role will be part of the Equipment Qualification Team within this group.

The activities of the Senior Validation Engineer in Equipment are to:

• Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process.
• Development and approval of Validation Plans, FAT’s, IV/FTs (or SAT’s), PQ’s and reports etc. for Vial and Syringe filling and formulation equipment in line with GMP’s, regulatory requirements and corporate standards.
• Work with Engineering, Commissioning and Qualification, and external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests and Quality Risk Assessments (QRAES) to ensure the quality by design principles are being followed and requirements are tested in qualification documentation.
• Manage periodic review program in line with the site periodic review schedule.
• Collate and report on relevant validation data and metrics.
• Assist in the development and improvements of the equipment validation lifecycle process while ensuring continued compliance to all necessary regulations. In addition, provide input and guidance into multisite and local procedural requirements.
• Coordinate projects and prioritize workload in line with site priorities.
• Lead equipment qualification projects associated with the manufacturing areas at ADL for projects such as NPI’s and continuous improvement initiatives.
• Participate, when required, as a member of a multidisciplinary site and multisite teams, e.g. Cross Functional Investigation Team and change control GDE’s.
• Update and maintain Standard Operating Procedures (SOP's) in accordance with site and corporate requirements.
• Participate in regulatory inspections, regulatory filings and RTQ’s (response to questions).
• Attend and contribute to staff meetings and attend appropriate training sessions, as required.
• Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.

Basic Qualifications:

• Bachelor of Science/Engineering degree or equivalent.
• Knowledge of cGMP’s and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills
• 8+ years’ experience in a similar role

Preferred Experience:

• In depth experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
• Experience qualifying equipment, ideally filling and formulation systems within the aseptic manufacturing environment of drug product.
• Previous regulatory experience with regard to representing the site validation program in addition to supporting NPI regulatory marketing applications.
• In depth experience of Amgen Quality and Document Management Systems including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.
• Knowledge of Amgen manufacturing equipment or investigations into issues on equipment.