Requirements Education & Experience
Bachelor’s degree in Engineering, Chemical or Mechanical Engineering.
Preferred with some experience on industry, academic research, COOPs, etc.
Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.
Under close supervision, assists with or directly provides technical engineering support in process optimization strategies, upgrades, replacements, and modifications in the operations, manufacturing, or pilot plant environment. Ensures that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements.
1. Perform standard engineering work requiring application of standard techniques and procedures.
2. Complete routine technical tasks.
3. Prompt and regular attendance to workplace.
4. Other functions may be assigned.
1. On a daily basis, monitor operations of a unit operation or system and actively assist operations, maintenance or project personnel as required.
2. Routinely audit the operational performance and regulatory compliance of a limited number of equipment items or systems of minor to moderate complexity.
3. Routinely troubleshoot operational issues with individual equipment or skids.
4. Assist with the proposal, initiation, testing and implementation of proposed changes to process, utility and/or facility systems
5. Assist more senior engineers in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
**Other functions may be assigned.
Minimal years of experience in operations/manufacturing environment preferred. Exposure to or direct experience with regulated environments (i.e., cGMP, OSHA, EPA) preferred
• Working knowledge of pharmaceutical/biotech processes
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope.
Demonstrated skills in the following areas:
• Problem solving and applied engineering.
• Basic technical report writing
• Verbal communication