Title : Manufacturing Engineer

Location: Thousand oaks, CA

Duration: 12 Months Contract with possible extension

Description:

Looking for industry experience as a manufacturing engineer

The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop, improve and oversee the operation and reliability of equipment. The Engineer role will provide direct engineering technical support as follows:

- Identify, support, and/or lead implementation of engineering based improvements or

upgrades to the process equipment. This may include development of rationale for

improvement and identification of design requirements and then translation of requirements

into process equipment/system design, specification and supporting the construction,

startup, and validation of equipment.

- Be individually accountable for the verification deliverables.

- Assist in the identification of critical quality parameters and process attributes for new equipment.

- Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.

- Provide oversight for verification deliverables developed by outsourced/contract verification staff.

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

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

- Develop or oversee development of commissioning and function test plan for any equipment modifications and acquisition in line with CQP, Automation Systems, 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.

- Monitor systems to identify performance risks and implement risk reduction strategies.

- Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis involving multidisciplinary site teams and implementation of corrective/preventive action.

- Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations.

- Lead and provide ad hoc technical support and guidance in a timely manner for manufacturing and maintenance on equipment troubleshooting.

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

- 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.

- Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time.

- Provide concise and clear documentation for actions taken on systems.

Preferred Qualifications / Skills / Experience

• Bachelor's degree in engineering-related field

• 5 years of relevant work experience with 3 years’ experience in operations/manufacturing

environment

• Direct experience with regulated environments (FDA, OSHA, EPA, etc.)

• Working knowledge and experience with cGMP procedures and engineering practices on

pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment

• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production

• facility equipment/systems such as cell culture reactors, chromatography, filtration, as well as other

equipment needed to support these processes such as autoclaves, clean in place (CIP) systems,

washers, clean steam, etc.

• Process automation knowledge – understanding of automation infrastructure, current technologies,

and automation project execution / verification.

Rupalim Dutta

Team Lead

rupalimd@aditiconsulting.com

(650) 376-0819