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Posted: 07/26/2024 Job Number: 39496

Job Description

Engineer

Top 3 Must Have Skill Sets:

Engineering and technical background (process equipment, troubleshooting, data driven tech skills)
Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering
Team work experience

Red Flags:

No work experience
No engineering or technical experience
No collaboration experience
No work gap of more than 3 months

Summary:

This engineering position supports manufacturing activities associated with manufacturing process equipment at Thousand Oaks (TO). 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.

Responsibilities:

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.

Skills:

Basic technical report writing and presentations
Verbal communication
Personal Organization
Dealing with and managing change
Technical (Equipment Specific)
Analytical Problem Solving
Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS)
Specialized equipment/process expertise
Ability to handle multiple projects/troubleshooting at the same time
Schedule development, facilitation and collaboration
Basic project management, project completion and follow-up
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Project Cost development
Conflict Resolution
Customer service in a technical setting
Management of contractors and vendors.
Experience in developing SOPs and delivering training
Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making

Basic Qualifications:

Master degree

Bachelor degree and 2 years of experience

Associate degree and 6 years of experience

High school diploma / GED and 8 years of experience

Preferred Qualifications:

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.

Pay range is $31 -36 $ per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.

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Meet Your Recruiter

Krista McIlwaine

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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.