Senior Process Engineer Global - Operations

AstraZeneca   •  

Coppell, TX

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 76 days ago

This job is no longer available.

Job Description

The Senior Process Engineer is responsible for providing technical support for operations, act as subject matter expert for multiple processing operations, initiates and manages capital and non-capital improvement projects, and provides technical leadership within the process engineering team. Will be required to supportinvestigations and correction of process related problems and deviations from standards. May be asked to mentor junior engineers. You will bring relevant experience in large scale chemical manufacturing to execute and deliver new projects and interacting and collaborating with other disciplines as well as external contractors.

Job Responsibilities

  • Work effectively with others from diverse backgrounds and demonstrate capability to adapt to new, different, or changing requirements. Display strong moral principles and work ethics while demonstrating initiative. Maintain a professional presence and display responsible behaviors.
  • Develops conceptual strategies, processing schemes, feasibility studies, PFD’s, and detailed scopes of work.
  • Develops detailed process design, including P&ID mark-ups, equipment process data sheets, process piping design, and ancillary equipment.
  • Identify and execute projects to increase safety, reduce product cost, improve product quality, improve yield, and reduce material usage.
  • Work and lead several different projects and be able to prioritize these projects.
  • Works with contractors and project teams on buildout and expansion of facility while demonstrating confidence in voicing concerns and driving the project team to deliver a usable product for the end internal customer.
  • Assists in developing control strategy and instrument process design, including emergency and shutdown procedures, instrument specification sheets, control ranges, alarm points, and automation strategy.
  • Authors, updates, reviews, and approves area procedures and master batch records to ensure correct content and compliance with Good Manufacturing Practices.
  • Designs studies, executes experiments and perform data analysis.
  • Writes study proposals, progress reports, development reports, and various technical memo’s.
  • Evaluates new technologies to improve the commercial production process.
  • Supports scale up activities from R&D to production.
  • Provides miscellaneous overhead support of facility.
  • Supports the assurance of a robust manufacturing process for the current registered process as experience is gained post launch.
  • Sets up robust process for trouble shooting.
  • Acts as an effective change agent.
  • Acts as a key player for the expansion of projects to increase scale of manufacture.
  • Trains and mentors new process engineers and interns to develop them into capable engineers.
  • Investigate deviations from standards of manufacturing process using effective root cause analysis tools. Recommending and implementing effective corrective and preventative actions.
  • Generating, evaluating, and implementing innovative and creative solutions.
  • Serve as subject matter expert for technical projects.
  • Capable of generating a project scope and cost plan to effectively draft a capital request.
  • Develops product and process knowledge in multiple process train areas.
  • Contributes to equipment URS development and retrofit. Participates in equipment FAT’s, SAT’s, etc.
  • Participate in Quality Risk Assessments and process hazards analysis activities.

Education, Qualifications, Skills and Experience

Essential

  • Bachelor of Science degree in Chemical Engineering or other related technical discipline, plus a minimum of 7 years of direct chemical processing experience preferably in a pharmaceutical production environment
  • Experience in reading/writing P&ID’s, Process Flow Diagrams, and mass and energy balances
  • Experience in batch type operations
  • Experience with large scale, high volume operations
  • Experience with automation controls
  • Demonstrated leadership skills
  • Excellent verbal, written, and interpersonal communication skills are essential.
  • Proven direct project management leadership

Desirable

  • Capital project experience (CAPEX)
  • High temperature and high-pressure applications
  • Experience with pressure filter dryer technology
  • Root cause investigation training
  • Lean certification
  • Experience in the following areas: Process Chemistry scale up; validation activities for commercial production; reactors and drying processes; and, setting up new equipment trains – (URS, FS, PID, IQ, OQ, PQ)
  • Experience with Statistical Process Control, Process Capability Analysis, and Risk Assessment/Management/.
  • Working knowledge of SAP

Key Relationships to reach solutions

Internal

  • Facilities
  • Quality
  • Global Engineering
  • Operations

External

  • Equipment Vendors
  • External Contractors

Job reference: R-048886