Pharmaceutical Process Engineer

3 weeks ago

Thousand Oaks, United States ACL Digital Full time

Job Title: Process Engineer

Location: Thousand Oaks, CA

Duration: 05 Months contract


Description:

FULLY ONSITE AT USTO - no opportunity for remote

Standard business hours, some possibility for OVT


Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering and manufacturing background.


Top 3 Must Have Skill Sets:

1. Engineering and technical background (process equipment, troubleshooting, data driven tech skills)

2. Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering

3. Team work experience

4. Pharmaceutical equipment management background


The Engineer role will provide direct engineering technical support as follows:

• Be individually accountable for the verification deliverables

• Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.

• Assist in development and review of User Requirements Specifications (URS).

• Suggest design modifications to address risks and design in quality and safety.

• Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and standards.

• Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout

• Ensure safety during commissioning, validation, maintenance and manufacturing activities

• Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed

• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.

• Responsible for equipment troubleshooting in a timely manner.

• Identifying reliability improvements for assigned equipment to improve equipment uptime.

• Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.

• Provide ad hoc technical support and guidance for manufacturing and maintenance

• Provide concise and clear documentation for actions taken on systems


Demonstrated skills in the following areas:

o Problem solving and applied engineering.

o Basic technical report writing and presentations

o Verbal communication

o Personal Organization

o Dealing with and managing change

o Technical (Equipment Specific)

o Analytical Problem Solving

o Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS)

o Specialized equipment/process expertise

o Ability to handle multiple projects at the same time

o Schedule development, facilitation and collaboration

o Basic project management, project completion and follow-up

o Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.

o Negotiation, persuasion and facilitation Collaboration

o Project Cost development

o Conflict Resolution

o Customer service in a technical setting

o Management of contractors and vendors.

o Flexibility to work off-hours and fully on-site


Basic Qualifications

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

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