We are seeking a Senior Engineering Specialist to join our team. In this role, you will be responsible for providing process, technical, and validation support operations, both for ongoing manufacturing processes and new product introductions. You will play a crucial role in the development of new components, products, processes, systems, and facilities.
Key Responsibilities:
- Provide technical and validation support for manufacturing and new product introduction.
- Design, author, review, approve, and execute process development studies to support new product introduction and ongoing manufacturing support.
- Offer technical input for quality notifications by authoring, reviewing, and approving investigations.
- Manage equipment commissioning and qualification programs.
- Design, author, review, approve, and execute qualification/validation documentation and studies.
- Perform data analysis and make informed decisions/recommendations based on the analysis.
- Support continuous improvement initiatives through Lean Six Sigma methodologies.
- Lead and actively participate in projects, system failure investigations, and investigation reports.
- Execute and develop change controls.
- Conduct root cause analysis of system failures using standard tools and methods.
- Act as a technical engineering representative for internal technical group discussions and global technical forums.
- Participate and/or lead cross-functional teams and liaise with vendors or above-site groups.
Requirements:
- Bachelor's degree or higher, preferably in a Science, Engineering, or other Technical discipline.
- Prior work experience in manufacturing, preferably in a GMP setting.
- Considerable experience in a comparable role: would typically have experience operating as a senior professional and adding considerable value to the business;
- Demonstrated technical leadership and delivery of complex cross-functional/cross-site projects.
- Expertise in multiple aspects of aseptic processing.
- Strong problem-solving and analytical skills.
- Excellent communication and teamwork abilities.
- Attention to detail and ability to manage multiple tasks simultaneously.
