Engineer II -(Associate)

Summary
We are seeking an Engineer II to support sterile supply departments by managing documentation, investigations, and process improvements. The ideal candidate will have strong technical writing skills, leadership abilities, and experience in biologics, vaccines, or bulk sterile manufacturing. This role involves authoring GMP documentation, supporting deviation management, and driving continuous improvement initiatives.

Responsibilities
• Author, support, update, and lead documentation updates, including SOPs, batch records, change control documents, technical protocols, validation documents, and other GMP documentation.
• Support deviation investigations, including assessment of product impact, root cause analysis, and corrective/preventative actions.
• Assist in writing quality incidents and deviation reports.
• Provide support for equipment and facility projects across sterile supply departments.
• Lead continuous improvement projects to enhance compliance, reduce costs, and standardize processes.
• Analyze complex issues from multiple perspectives (safety, compliance, automation, equipment, process, and personnel) to identify and resolve root causes.
• Design, conduct, review, and approve experimental protocols as needed.
• Provide on-the-floor support for complex operational and technical issues.
• Lead projects to improve process performance, including Corrective/Preventative Actions (CAPAs), right-first-time initiatives, and efficiency improvements.
• Support team safety, environmental, and compliance objectives.
• Manage project timelines, ensuring compliance and customer deadlines are met, escalating potential delays and developing remediation plans as needed.
• Collaborate effectively with Operations, Quality, Planning, project teams, and external vendors.

Education
• B.S. or B.A. in Engineering, Sciences, or related discipline.

Experience
Required:
• 2-4 years of experience (combination of co-op and real-world experience acceptable).
• Strong technical writing skills.
• Highly developed communication, leadership, and teamwork skills.
• Ability to manage projects and meet deadlines.

Preferred:
• Experience in biologics, vaccines, or bulk sterile manufacturing facilities.
• Experience with Change Control processes.
• Background in Deviation Management and Investigations.

Additional Information
• Location: Onsite role.
• Schedule: Full-time.
• Work Environment: GMP-regulated sterile manufacturing setting.
• Key Attributes: Detail-oriented, proactive problem solver, strong leadership and collaboration skills, and a commitment to continuous improvement.