Great role for a qualified engineer to provide technical expertise to the sterile technical team for the duration of a facility upgrade project.
The Sterile IPT De-Commissioning and Validation Engineer will provide technical expertise to the sterile technical team for the duration of the facility upgrade project.
The project will focus on the de-commissioning of a portion of the facility, along with completing continuous improvement works to the facility. The team working style is one of collaboration, coaching and facilitating to provide technical solutions to the IPT team to support a High Performance Organisation.
- Accountable for supporting all technical components of the process to deliver an effective and efficient facility upgrade
- Responsible for actively participating in the Tier process to manage technical projects and proactively resolve issues before they impact the business priorities
- Be an active member within the cross functional project team who will lead and execute all de-commissioning & equipment close out activities for the assigned portion of the project
- Participate and comply with the Client Quality Management System (QMS) requirements and the EHS guidance chapters, including ownership, as relevant to you
- Provide ongoing coaching and support to the cross functional team members, to share their technical knowledge and promote best practices
- Ensure delivery of all assigned tasks and activities for the project as assigned
- Provide Technical stewardship, equipment resource planning and validation schedules
- Ensure highest Quality & Compliance standards
- Provide Technical expertise within a wide range of technical projects within the IPT, such as the execution of new equipment, authoring and execution of protocols, completion of Risk assessment, and generation of project documentation while adherence to safety requirements for all activities
RELATED QUALIFICATIONS AND EXPERIENCE REQUIRED:
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, engineering, etc)
- At least three year's experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical role in a manufacturing environment
- Knowledge of and experience in De-commission and validation activities
- A strong understanding of regulatory and validation requirements
- Demonstrated leadership skills with a continuous improvement focus
- Project Management Experience leading projects
- Degree or 3rd level qualification (Production, Mechanical, Process, Industrial, Electrical)
- Desirable evidence of Continuous Professional Development
- Desirable for Six Sigma Green Belt
- Desirable project management qualification such as PMP etc.
- Process and technology background essential
- Demonstrated ability in holding project team members responsible for results and being decisive about non-performers
- Demonstrated ability to work on own initiative within the parameters of a highly regulated GMP environment
- High technical writing standard and strong attention to detail
- Ability to generate, review, and execute validation protocols and reports
- Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
- Demonstrated high level of problem solving and facilitation skills
- Advanced PC skills such as Excel, Word, PowerPoint
- Stakeholder management of multi decision makers, colleagues, peers and cross functional teams
- Ability to perform process development studies for new product introductions (*Desirable)
- Thermal mapping experience (*Desirable)
Morgan McKinley is acting as an Employment Business in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.