Specialist, Engineering

Job Description

Specialist, Engineering

The function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role encompasses technical services support in the areas of deviation management, equipment and automation systems, validation, and product franchise.  Specific assignments may be focused in one area or span across multiple areas of focus.

Responsibilities include:

• Provide on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation or process troubleshooting or to provide immediate responses to deviations and potential deviations.

• Conduct real time investigations with the goal of fully understanding root cause and product impact within three days of event discovery.

• Perform deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment.  Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.

• Manage investigation and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible, including change control. Preparing source documentation for regulatory filings, supporting requests for regulatory inspections related to process overviews, investigations, projects and validation.

• Complete projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times

• Author updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures).

• Support team safety, environmental and compliance objectives.

• Manage investigation and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible, including change control.

• Execute projects and assigned studies in a right-first-time manner.

• Collaborate effectively with the area Managers, Operators/Technicians, support groups (Mechanical Services, Trades, Automation, Technology), Quality, and Planning.

• Perform customer complaint investigations, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment.   Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc

• Actively use and champion the use of Lean Six Sigma (LSS) and our Company Production System (MPS) tools, both in problem solving and day-to-day operational activities.

Position Qualifications:

Education Minimum Requirement:  

• B.S. or B.A. in Mechanical or Chemical Engineering degree or other science degree

Required Experience and Skills:

• Engineering or science educational background   

• Demonstrated ability to work both independently and as a part of a team.

• Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills

• at least 1 year of relevant work experience

Preferred Experience and Skills:

• 18 months of relevant work experience