Associate Engineer - II

We are seeking a highly motivated and detail-oriented professional to join our team supporting biologics, vaccine, and bulk sterile manufacturing operations. This role provides critical technical and operational support to ensure compliance, process improvement, and high-quality output. The successful candidate will partner closely with cross-functional teams, including Operations, Quality, Planning, and external vendors, while contributing to continuous improvement projects, deviation investigations, and technical documentation updates. This position offers an exciting opportunity to work on complex manufacturing processes and make a measurable impact on product quality and operational efficiency.

Responsibilities

• Support deviations by assessing product impact, identifying root causes, and implementing corrective and preventive actions (CAPAs).
• Author, update, and/or lead documentation revisions, including SOPs, batch records, change control documents, technical protocols, and validation documents.
• Assist with equipment and facility projects across Culture Media, Weigh and Dispense, and Black Widow Spider operations.
• Participate in continuous improvement initiatives to increase compliance, reduce costs, and standardize processes.
• Analyze complex operational issues from multiple perspectives (safety, compliance, automation, equipment, process, and personnel) to identify solutions.
• Design, conduct, review, and approve experimental protocols as needed.
• Provide on-the-floor support for complex operational and technical process/equipment issues.
• Manage projects aimed at improving process performance, preventing deviations, and increasing efficiency.
• Support team safety, environmental, and compliance objectives.
• Collaborate effectively with internal teams and external vendors to achieve project and operational goals.

Education

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

Experience

• 2–4 years of relevant experience (co-op/internship experience can be included).
• Strong technical writing, communication, leadership, and teamwork skills.
• Preferred: deviation management, experience in biologics/vaccine/bulk sterile manufacturing, and Change Control processes.

Additional Information

• This role may require on-the-floor support and occasional off-shift work.
• Project timelines must be managed to meet key compliance and customer deadlines.
• Opportunity to engage in continuous improvement and process optimization projects.