Process Engineer

Katalyst CRO; Lebanon (IN); On-site; USD 90,000 - 125,000; Full time

Job summary

Join a leading company in pharmaceutical manufacturing as a Process Engineer. You will play a pivotal role by authoring and revising essential documentation, generating training materials, and collaborating across departments to ensure the success of equipment and process operations. Suitable candidates will have a solid background in engineering and experience in the pharmaceutical sector.

Qualifications

• Bachelor's degree in Engineering or related field required.
• Proficient in MS Word and Visio for document editing.
• Experience in pharmaceutical manufacturing preferred.

Responsibilities

• Author and revise SOPs, risk assessments, and engineering protocols.
• Draft training materials and provide hands-on support for equipment startup.
• Work cross-functionally to support multiple departments.

Skills

Documentation

Collaboration

Problem-solving

Education

Bachelor Degree in Engineering or related

Tools

MS Word

Visio

Job description

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• Work alongside and supplement our client's site process engineers at the site
• Author, format, and revise SOPs, ESIs, risk assessments, verification documents, PSQ protocols, engineering protocols, and OCSs as needed.
• This will include the formatting of documents for consistency of layout; to include references to other documents and systems; embedded pictures, videos, and other media to facilitate instruction; and troubleshooting of formatting errors.
• Generate/draft training materials in parallel with procedures and other equipment/process specific documentation
• Observe equipment and system startup and C&Q activities in the facility as-needed to support document drafting and revision
• Draft documents using client's templates and following the examples laid out in existing documents generated by the site
• Work cross-functionally to support multiple departments
• Required to complete OSHA 10-hour construction training.
• Provide support drafting content for change controls
• Provide hands-on support with equipment startup and testing
  
  

Responsibilities

• Work alongside and supplement our client's site process engineers at the site
• Author, format, and revise SOPs, ESIs, risk assessments, verification documents, PSQ protocols, engineering protocols, and OCSs as needed.
• This will include the formatting of documents for consistency of layout; to include references to other documents and systems; embedded pictures, videos, and other media to facilitate instruction; and troubleshooting of formatting errors.
• Generate/draft training materials in parallel with procedures and other equipment/process specific documentation
• Observe equipment and system startup and C&Q activities in the facility as-needed to support document drafting and revision
• Draft documents using client's templates and following the examples laid out in existing documents generated by the site
• Work cross-functionally to support multiple departments
• Required to complete OSHA 10-hour construction training.
• Provide support drafting content for change controls
• Provide hands-on support with equipment startup and testing
  
  

Requirements

• Bachelor Degree in Engineering or related
• Proficient in applications such as MS Word and Visio to produce and edit documents and diagrams
• Substantial experience in pharmaceutical manufacturing using single-use disposable systems
• Experience in manufacturing biologics is preferred and gene therapy a PLUS
• Startup facility experience is preferred
• Project management experience is preferred
• C&Q (commissioning, qualification) engineering experience preferred/plus

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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