Project Manager

4 weeks ago

Thousand Oaks, United States Calsoft Labs Full time

FULLY ONSITE AT USTO Standard business hours Looking for a PM who will support manufacturing plant/ engineering group

*Copy of AMAGJP00011920, AMAGJP00012143. Please do not resub previously presented candidates. EM FEEDBACK FROM CANDIDATE POOL: It seemed like the applicant pool lacked process/utility Engineering technical experience and was more suited for quality roles*

This engineering position supports projects that associated with cGMP equipment and facilities at Client Thousand Oaks (ATO). The engineer will lead activities in alignment with the engineering workstreams (i.e. Client s Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & facilities design and compliance, project management, etc.). The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment. The engineer must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.

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, Client 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. #J-18808-Ljbffr

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