Purpose

As a result of volume driven growth with our client, the Corporate Engineering Teams Engineering Technical Authority is hiring a Technical Lead to support the design and implementation of new Syringe Inspection Lines. The successful candidate may be requested to support Filling, Warehouse / Cold-Storage and Parts Prep areas as required.

The Engineering Technical Authority (ETA) within the company’s Corporate Engineering leads the design for critical projects as well as provides technical expertise and direction across their global operations network. This position is part of the ETA organization that includes Process Systems, Facilities and Utilities, Site Project Engineering, and other engineering technical functions. The Technical Lead will report to the Process Technical Lead for the project, who is also a member of the ETA.

As part of the new DP project, the company will have a strong focus on delivering a digitally enabled and sustainable facility aligned with our digital manufacturing strategy and our aggressive corporate sustainability goals. The successful Technical Lead will have extensive experience in Automatic Inspection Equipment, Syringe Filling, Material Logistics and Drug Product Storage Area design, development, and implementation.

The successful candidate must be willing to relocate to the project site for the duration of the projects. The position requires the ability to travel internationally as needed to deliver the project including overnight stays.

Responsibilities

• Experience working directly with automatic inspection equipment

• Delivery of capital projects. So, would expect someone to have worked on a project sized $50m or similar.

• Technical knowledge of the equipment of automatic inspection equipment. Would expect them to have vision analysis, integration with the facility, design, test cases for inspection route, and knowledge of regulatory requirements.

Qualifications

• Bachelor’s degree and over ten (10) years of experience in Engineering or a related technical discipline AND Experience leading teams, projects, and programs

Preferred -

• Extensive experience with Automatic Syringe Inspection Equipment design and delivery.

• Extensive experience in the delivery of capital projects as part of the design or process team.

• Proven ability to provide direction and oversight to equipment vendors to deliver for the capital projects

• Experience in providing technical support to manufacturing facilities.

• Proven experience and track record of compliance in a highly regulated environment

• Demonstrated ability to effectively lead and partner in a complex, matrixed organizations

• Demonstrated experience in selection of and implementation of design elements for improved sustainability.

• Extensive experience in system Design, Install, Turnover and CQV.

• Extensive experience in generation of Design Qualification documentation in addition to reviewing/approving both design and CQV related documentation.

Competencies:

Proven ability to work as part of cross functional team to deliver project requirements.

Excellent communications skills.

Strong analytical skills to identify potential improvement opportunities

Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, asset insurance, etc.) to stay at the forefront of technology implementation

Knowledge of applicable regulations (e.g. cGMP, building codes, fire codes, electrical codes, OSHA, LEED, Energy codes, Mechanical codes, Boiler and Pressure Vessel codes) to ensure compliance. Represent the company with outside firms, technical societies and regulatory bodies.

Ability to develop, implement and utilize tools to drive efficiency in meeting business needs; establish measure and evaluate performance metrics, taking actions based on results.