Engineering Assistant I - Portsmouth, United States - Unicon Pharma Inc

Description

Job Description

Job Description

Description:

The Engineer Co-Op supports ongoing operations at the Portsmouth, NH site through technical assistance as it relates to manufacturing and process systems.

The focus of the role is supporting the manufacturing engineering department on their objectives and developing an understanding of the engineering function and biologics processes.

Responsibilities of the Process Engineering function include both tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business.

The role reports into the Manufacturing Engineering department at the site

Key Accountabilities and Duties:

Performs all work safely and meets the requisite training requirements
Develop a basic understanding of the cGMP fermentation and purification processes and equipment
Supports engineering in resolution of major equipment breakdowns and quality issues
Provide SME support to Manufacturing and other departments for the design and operation of process equipment.
Gain experience within biologics industry
Conduct troubleshooting and technical analyses on manufacturing equipment and processes
Assist with tech transfer of new processes into the facility
Assist with modifying/developing preventative maintenance plans and creating spare parts
Assist with the planning and execution of plant projects involving equipment changes and process improvements
Execute commissioning protocols (installation, operation, CIP/SIP, wet testing)
Complete change request tasks to support project completion
Assist the Quality department with deviation investigations
Participate in root cause analysis investigations for equipment issues
Assist with completion of CAPA actions

Review/revise Engineering and Manufacturing related SOP's, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, and error prevention activities.

Initiate updates to Engineering documents including engineering drawings
Author commissioning protocols (installation, operation, CIP/SIP, wet testing).
Remain up to date on all assigned training activities
Perform other duties as assigned

Minimum Required Qualifications/Skills:

High School Diploma or Equivalent; pursuing BS in Engineering Discipline

Preferred area of study:
Chemical Engineering
Completion of sophomore year (typically 60 credits)

Education in the application of engineering principles to plant systems; Biopharmaceutical/process experience preferred, but not required at this level.

Proficient with Microsoft Office Suite with focus on Outlook, Word, PowerPoint and Excel.