We are seeking a Senior Technical Project Lead for an initial 12-month contract role.
The successful candidate will be responsible for scoping and executing technical projects in support of Drug Product manufacturing, spanning Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation, Device Assembly, Inspection, Filter/Filter Integrity Testing areas.
This includes the qualification of new equipment and implementation of associated reliability and maintenance programs.
Role Responsibilities:
* Project management and execution of assigned projects, including project prioritization, resources management, status management and external communication.
* Collaboration with various stakeholders to scope projects and ensure requirements are satisfied.
* Project input will span from concept through design, construction, commissioning and operation.
* Coordinating the introduction of new processes, equipment and materials, including problem solving and troubleshooting equipment issues prior to qualification & start-up.
* Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.
* Ability to translate strategic/emerging technology solutions into pragmatic executable plans.
* Development and management of change controls.
* Participation as a member of multidisciplinary site and multisite teams.
* Development of detailed specifications, engineering documents, protocols and standard operating procedures.
* Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
* Works in a collaborative manner with System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.
* Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures.
* Support a safe working environment by complying with environmental health/safety practices, rules and regulations.
Required Skills and Qualifications:
* Bachelor's Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience.
* Typically, 3+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly.
* Proven project management experience.
* Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment is advantageous.
* Demonstrated experience in a GDP Compliant environment.
* Experience in MS Office, MS Project, Change Control & Document Management Systems.
* Proven ability working cross functionally, delivering technical solutions and implementing improvements.
* Technical report writing and communication/presentation skills.