Global Technical Engineering Expert
Norgine, United Kingdom

SCOPE OF ROLE:

Geographical : Global reach with primary focus on a Norgine manufacturing site

Span of control: Capital engineering projects within Global Technical, direct support to Norgine Manufacturing sites and potentially to CMOs within Mamp;S network

Single encumbent role

MAIN PURPOSE:

To Provide Engineering support for new and existing production processes for all Norgine sites, Contract Manufacturing Organisations (CMO’s) and Partners when required. Identifying process improvements then successfully implementing these improvements by leading Engineering projects.

KEY RESPONSIBILITIES amp; ACCOUNTABILITIES:

• Lead improvement projects including site CAPEX and Site Process Improvement Roadmap projects. For projects incorporating new equipment provision, this includes both offsite activities e.g. factory acceptance testing, as well and on site activities.
• Provide advanced Engineering Technical support utilising lean six sigma techniques for investigations linked to Quality Events, Customer Complaints and IMC actions. Provide technical recommendations, co-ordinate and execute CAPA’s.
• Provide Engineering Technical support and assistance with formal reporting of approved GTM projects for the introduction of new products, new processes, line extensions, technical transfers and continuous improvement initiatives.
• Provide Engineering Technical support for Process Validation and Performance Qualification of new and existing Products at all Norgine sites.
• Provide Engineering Technical support for Local Change Controls. Provide support for impact assessments. Support and/or coordinate the action plans.
• Provide assistance to the Head of Engineering with the administration of Site Capex projects including Budget control and reporting.
• Liaise with equipment suppliers when necessary for solving complex equipment issues.
• Management and coordination of equipment change / improvement trials.
• Subject Matter Expert for Equipment and Process.
• Reduce costs of potential projects through negotiations with potential suppliers.
• Control all aspects of the Norgine ICV process within any projects when required.
• Writing, reviewing and performing Validation protocols to ensure projects are compliant to the ICV process.

Key Committee Memberships:

1. Site CAPEX

RELATIONSHIPS:

• Report directly to the Global Technical Head of Engineering with close support provided to the other functions within the GTM team.

1. Work cross functionally to support the GTM team on approved projects with representatives from global and local departments.

1. Progress reporting support of project status to Global Technical Management amp; Project Sponsors

SKILLS amp; KNOWLEDGE

• HNC or equivalent in an engineering / science discipline.

• Extensive experience of the pharmaceutical industry with at least 5 years of experience of working within the industry

• A proven self-starter with a high degree of initiative, ability to work independently and as part of a team. Strong teamwork and interaction skills required

• Proven ability in leading Engineering Projects.

• Trained and certified as a Lean / Six Sigma Green or Black belt with demonstrated experience in the participation of root cause analysis investigations utilising lean Six Sigma tools

• Ability to support cross functional projects to deliver against key project milestones and deadlines

• Disciplined and enthusiastic approach that motivates others, with excellent influencing skills and the ability to establish effective working relationships with personnel at all levels

• Mind-set to question the current situation and have the drive to make improvements

• Excellent verbal and written communication skills, in English (Other languages desirable e.g. French or German) with the ability to present effectively to small groups

• Thorough working knowledge of current Good Manufacturing Practices.

• Computer literacy i.e. MS Office, MS Project.

Job Rewards and Benefits