Sr. Production Engineer

Description

ESSENTIAL FUNCTIONS :

• Studies process and equipment to identify problems and opportunities. Provides technical guidance and instruction to APAP Operations Team regarding troubleshooting and debottlenecking efforts.
• Ensures that all processes operate within defined and validated limits.
• Conducts training for APAP Operations Team on new equipment and process changes.
• Represents the APAP Operations Team in developing and implementing capital projects. Activities include project scoping, operating requirements, process controls, process tolerances, alarm rationalization, and validation.
• Prepares periodic reports that summarize production rate, yield, rework status, quality condition and that summarize any special projects or problems that have been encountered.
• Identifies and implements changes to reduce product cost by increasing production rate, improving yield, reducing downtime, improving equipment efficiency, etc.
• Participates in periodic process audits with management personnel with respect to safety, environmental, quality, production, and cost.
• Generates, reviews, and updates documentation for managing the process, including operating reports, batch records, P&IDs, etc. Reviews operating reports and batch records for accuracy and improvements.
• Participates in customer and regulatory audits.
• Investigates process deviations, inquiries, complaints and equipment loss incidents and identifies corrective and preventative actions where needed. Coordinates implementation of corrective measures.
• Actively supports site continuous improvement process and serves on teams as needed to improve the workplace and increase efficiency and productivity.
• Other duties as assigned with or without accommodation.

MINIMUM REQUIREMENTS :

Must have a B.S. in Chemical or Mechanical Engineering

Must possess knowledge of chemical and chemical engineering principles in order to solve production, quality and throughput problems.

5-10 years of experience in chemical or bulk pharmaceutical (API) manufacturing operations

Understanding of GMPs (ICH Q7) and process validation

Understanding of Six Sigma and Lean Manufacturing tools and concepts

Experience in root cause analysis

Experience with change control / management of change

Demonstrated technical and leadership skills including oral / written communications, conflict resolution, decision making and sufficient financial acumen to interpret cost analyses and other reports.

Ability to plan and execute tasks on multiple projects simultaneously.

Must strive for continuous improvements in all work activities.

Self-motivated, Action-oriented, Technical Skills, Problem Solving, Informing, Organizing

RELATIONSHIP WITH OTHERS / SCOPE :

WORKING CONDITIONS :

DISCLAIMER :

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.