Chemical Process Engineer

Endo•Raleigh, NC

18h•Onsite

About The Position

SUMMARY OF POSITION: The Production Engineer will function as a part of the APAP Operations Team. The Production Engineer will apply technical skills to manage day-to-day production, optimize plant operation, resolve operational issues, and investigate process deviations. The Production Engineer will provide technical assistance to the APAP manufacturing employees to ensure that production targets are met while complying with all applicable Safety and Quality rules and regulations

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.
1-5 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

Responsibilities

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.