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Pharmaceutical Process Engineer SME
Pharmaceutical Process Engineer SMEInsight Global • Owings Mills, MD, US
Pharmaceutical Process Engineer SME

Pharmaceutical Process Engineer SME

Insight Global • Owings Mills, MD, US
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Day to Day :

  • Individuals in this position are responsible for planning, organizing, researching, performing preliminary and detailed design, preparing and reviewing documentation.
  • This position receives general administrative direction from the division manager and is responsible for design of one or more projects of varying size and complexity.
  • Coordinate project documentation and direct CAD designers for the preparation of design drawings. Possess ability to interpret applicable regulations and standards. Provide SME support for regulatory audits and inspections.
  • Coordinate project design with other engineering disciplines.

Must Haves :

  • Bachelor's degree from an accredited university in Chemical Engineering, Biochemical Engineering, or a related field
  • 10 years of applicable experience with pharmaceutical manufacturing processes and equipment, FDA regulations, and cGMP guidelines
  • Applicable project experience with cross-functional engineering teams
  • Experience with Lean Manufacturing and Six Sigma methodologies
  • Understanding of process validation and quality control
  • Understanding of pharmaceutical safety protocols and risk management
  • Strong technical writing skills for documenting and reporting

    • Proficiency in development of the following pharmaceutical design documentation :

  • User Requirement Specifications (URS),
  • Process analytical and controls strategy,
  • Product capacity verification calculations,
  • Raw material and finished goods format requirements,
  • Quality control, in-process testing, and Lab strategy,
  • Product containment limits,
  • Production and technical transfer details,
  • Media, Energy, and Mass balances,
  • Materials handling strategy,
  • Value stream mapping,
  • Batch documentation strategy,
  • Equipment campaign, turnaround and cleaning strategy,
  • Operational manning estimates,
  • Manufacturing, process equipment, and process utility descriptions,
  • Process equipment sizing and specifications,
  • Process equipment datasheets,
  • Process utility requirements.
  • Standard Operating Procedures (SOP), work instructions, operator training guides, and preventative maintenance instructions,
  • SME support for commissioning and qualification of equipment, utility systems and facilities, including IQ, OQ, and PQ,
  • Process functional specifications,
  • Process Block Diagrams (PBD),
  • Process Flow Diagrams (PFD),
  • Process and Instrumentation Diagrams (P&ID)

    • Also :

  • Strong problem-solving and analytical skills
  • Demonstrated leadership, interpersonal, and communication skills
  • Ability to perform field work that will include walking, kneeling, sitting, standing, climbing stairs and / or ladders
  • Willingness to travel to client sites
  • Ability to interact with customers to gather critical information
  • Ability to manage multiple projects and deadlines
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