Manufacturing Process Engineer

Use Your Power for Purpose

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring that customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you will play a key role in accelerating the delivery of medicines to the world. Your innovative ideas and proactive actions will help us imagine new possibilities and bring them to life, ensuring that our solutions are both timely and effective. Your contributions will be essential in ensuring that our manufacturing processes are efficient, reliable, and of the highest quality, ultimately helping us deliver life-saving medicines to those who need them most.

What You Will Achieve

In this role, you will:

• Serve as the manufacturing area's technical SME, providing expertise in fields such as the process, equipment, automation, documentation.

• Act as a Manufacturing Point of Contact for operator-support and issue resolution.

• Acts as a departmental liaison with primary support groups such as engineering, technical services, quality control, quality assurance, development, and utilities and collaborate with the aforementioned groups to ensure a robust manufacturing operation.

• Capable of identifying technical problems and solving them with minimal guidance. Ability to analyze operational process issues and automation challenges to recommend / initiate appropriate corrective and preventative actions. 

• Expertise in the Standard Work Plan and ability to coordinate batch activities with other Process Centric Teams (e.g., other manufacturing groups, Tech Services, QC, QA) to meet plan of record.

• Coordinate activities with maintenance to schedule routine work and to resolve corrective mechanical issues without impacting production operations.

• Act as AMPS (Agile Manufacturing Production System) subject matter expert for process. Author- change requests and participate in design reviews.

• Spend time on the production floor to proactively identify areas for improved efficiencies and ensure that product quality is maintained through all phases of production including operational parameters of manufacturing equipment, automation control, processing dynamics, and integrated utilities to identify and resolve quality, and technical, risk to manufacturing. 

• Support batch record and SOP revisions, commitment ownership, project management and investigations as needed. Review and contribute to applicable documentation (i.e.  MBRs, SOPs, etc)

• Participates in process operational improvements

• Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise, and coach their teams.

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelor's degree with at least 2 years of experience; OR a Master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a High school diploma (or equivalent) and 8 years of relevant experience

• Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding

• Working knowledge of Food and Drug Administration Regulations and Good Manufacturing Practices

• Requires general knowledge of scientific principles, technical knowledge of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on assigned production area.

• Proficiency in Microsoft Applications

• Ability to work effectively in a team environment and collaborate with cross-functional teams

Bonus Points If You Have (Preferred Requirements)

• Demonstrated experience in a relevant manufacturing environment

• Knowledge and experience with Vaccines processing and equipment

• Familiarity with Lean Manufacturing principles and Six Sigma methodologies

• Strong leadership and mentoring abilities

• Ability to adapt to changing priorities and work effectively under pressure

Physical/Mental Requirements

• Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis
• Proactive, with experience in high-performance teams, strong interpersonal and project management skills

• Strong written and verbal communication skills

• Excellent organizational skills and attention to de