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

Pharmaceutical Process Engineer SME

Insight Global • Owings Mills, MD, US

2 days ago

Job type

Full-time

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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Engineer Sme • Owings Mills, MD, US

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