Key Role:
A Process Engineering expert is sought to work on a cutting-edge manufacturing site, contributing to the success of our company. The ideal candidate will have hands-on experience with the latest technology and a passion for sustainability.
This 12-month contract presents an excellent opportunity for those looking to break into the biopharma industry or seeking valuable experience in technology transfer.
Job Overview
The selected individual will join our Process Engineering Group as a technical support specialist for new product introduction and commercial manufacturing. They will participate in cross-functional teams, liaising with vendors and other site groups.
Primary Responsibilities:
* Design, author, review, approve, and execute qualification/validation documentation and process development studies.
* Develop and implement change controls, ensuring compliance with established standards.
* Contribute to Kaizen events and provide technical input for quality notifications.
* Lead equipment/qualification validation programs and execute continuous improvement through Lean Six Sigma methodologies.
* Perform root cause analysis and resolve machine/system issues using standard tools and methods.
* Represent the technical engineering team in internal discussions and global forums.
* Ensure compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and cGMP practices.
* Work collaboratively to drive a safe and compliant culture.
* May be required to perform other duties as assigned.
Required Skills and Qualifications:
* Bachelor's Degree or higher in a Science, Engineering, or Technical discipline.
* Minimum 3 years of experience, ideally in manufacturing and preferably in a GMP setting.
* Demonstrable experience in leading technical projects and evidence of continuous professional development.
* Knowledge of process monitoring systems, automation systems, operational intelligence & data systems, and sterile filling processes would be beneficial.
* Excellent communication, presentation, and interpersonal skills are essential.
* Proficiency in Microsoft Office and job-related computer applications is required.
Benefits and Opportunities:
This role offers a unique blend of technical expertise and collaborative teamwork. The successful candidate will have opportunities for growth and development within a dynamic organization.
Additional Information:
Hybrid role with occasional shift support required based on program needs.