Sr. Production Engineer

7 days ago

Raleigh, North Carolina, United States Mallinckrodt Full time
Job Title
Sr. Production Engineer

Requisition

JR000014849 Sr. Production Engineer (Open)

Location

Raleigh, NC

Additional Locations

Job Description Summary
The Sr. Production Engineer will function as a part of the APAP Operations Team. The Sr. Production Engineer will apply technical skills to manage day-to-day production, optimize plant operation, resolve operational issues, and investigate process deviations. The Sr. 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.

Job 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:

Education:

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

Experience:

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

Preferred Skills/Qualifications:

Other Skills:

Competencies:

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:
  • The Sr. Production Engineer will report to the APAP Focus Factory Manager
  • The Sr. Production Engineer will work closely with the other APAP Sr. Production Engineers, Supervisors and Sr. Day Operator to coordinate tasks
  • Frequent interactions with the following functions will be required:
    • APAP production operators
    • QA and QC
    • Maintenance and Engineering
    • EHS
      • Periodic interaction/communication with all site departments and corporate groups
      • May work with outside engineering design firms, manufacturer's representatives, vendors, and construction contractors
WORKING CONDITIONS:
  • Works in an office environment, but will spend significant time in a multi-story bulk pharmaceutical (API) manufacturing plant that is partly outdoors
  • May be exposed to fugitive emissions of chemicals typical of chemical operations
  • Must be able to climb stairs and ladders for equipment installation review, monitoring and troubleshooting
  • Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses, earplugs, fire-resistant clothing and any other devices or equipment that may be required
  • Position is required to be periodically available for on-call nights/weekends
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.

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