Project Engineer

2 weeks ago

Thousand Oaks, United States ACL Digital Full time

Job Title: Project Manager/Engineering

Location: Thousand Oaks, CA

Duration:12 Months


Description:


FULLY ONSITE AT USTO

Standard business hours

Looking for a PM who will support manufacturing plant/ engineering group


Top 3 skills must have

EM FEEDBACK FROM CANDIDATE POOL: It seemed like the applicant pool lacked process/utility Engineering technical experience and was more suited for quality roles

1. Good Fundamental Leadership and Values

2. Good Fundamental Engineering

3. Good Fundamental Project Management

Looking for a PM who will support manufacturing plant/ engineering group


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

• Be individually accountable for the verification deliverables on key capital projects

• 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.

• Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).

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

• Recommend, evaluate, and manage performance of contract resources

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

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

• Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.

• 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

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

• Develop commission strategy

• Oversee development of validation protocols, Automation System Delivery

• Lead teams

Related Activities:

• Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.

• 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

• Assist in developing and project engineering & management metrics


Preferred Qualifications / Skills / Experience

• Bachelor's degree in engineering or another science-related field

• 2+ years of relevant work experience with 1+ 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

• Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution

• Experience with combination product / medical device quality systems verification

• Process equipment knowledge – cell culture, fermentation, purification, filling, and packaging

• Process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.

o Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus

• Demonstrated strong communication and technical writing skills

• Strengths in facilitation and collaboration / networking

• 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

• Good record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)

• Demonstrated skills in the following areas:

 Problem solving and applied engineering.

 Basic technical report writing.

 Verbal communication.

• Demonstrated Skills in the following areas:

 Basic technical presentations.

 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 at the same time.

• Demonstrated Skills in the following areas:

 Schedule development

 Facilitation

 Collaboration

 Basic project management

 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.

• Demonstrated Skills in the following areas:

 Negotiation, persuasion, and facilitation collaboration

 Project cost development

 Conflict resolution

 Leadership and team building

 Schedule and resources loading development

 Customer service in a technical setting

 Management of contractors and vendors.

 Flexibility to work off-hours.


Basic Qualifications

Doctorate degree OR Master degree and 2 years of experience OR Bachelor degree and 4 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

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