Visual Inspections Engineer
Team Horizon is seeking a Visual Inspections Engineer for a Visual Inspections Engineer. This person will be responsible for supporting strategy to qualify samples /streamlining processes and taking part in threshold studies.
Why you should apply:
* This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
* There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
* Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
* To work as a team member to support Visual Inspection operations in line with all safety, regulatory and organizational requirements.
* Develop and modify procedures as needed to support the manufacturing operation.
* Participate in process, equipment, and facilities validations efforts and projects implementations.
* Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy.
* Execute protocols in a timely basis to meet the project schedule requirements.
* Participate and lead (as required) Process FMEAs for Visual Inspection
* Establish, Lead and Optimize the process for certification of technicians for visual inspection.
* Establish and maintain the defect library.
* Establish and execute the process for the trending of Visual Inspection Defects
* Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements
* Provide Technical Input to guide the development of SOPs for Visual Inspection.
* Leadership of manufacturing and validation activities during project life cycle.
* Coordination with internal/external stakeholders for the evaluation of particles/defects
* Support of technical transfers for future product introductions to the site.
* Investigate process exceptions or malfunction incidents affecting the process.
* To liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required.
* Support the Production Team in ensuring that manufacturing process is enabled and maintained to meet the output and yield requirements.
What you need to apply:
* A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
* At least three (3) years of total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization.
* At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
* Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
* Experience in clean utilities is desirable.
* Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
* Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
* Understands and supports the principles of Perfect Performance. Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
* Expected to handle all day-to-day training, learning & development queries, if major problem can refer to Team Manager. Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities