Engineer Senior – Biotech Plant & Equipment Drug Substance Support (JP7606)
Thousand Oaks, CA. (Onsite Essential)
DSC Facilities and Engineering
1+ years (with likely extensions)
3 Key Consulting is hiring a Senior Engineer
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Candidate must have 3+ years of RECENT pharma experience
Candidate must have Drug Substance experience
Bachelors Degree in Engineering - chemical/ bio/ biochem
Candidate will be working on site
Candidate will have 5+ years of experience within Pharma or Biotech, minimum bachelors degree and experience troubleshooting integrated automated and mechanical systems on site.
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at client in Thousand Oaks (ATO). The engineer will lead activities in alignment with client’s Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. 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 Quality Assurance (QA) for GMP compliance. In addition, the engineer will support periodic review of manufacturing systems to ensure that they remain in a validated state. 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.
- Conduct and document periodic equipment validation reviews.
- 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.
- Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification.
- Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections.
- Participate in internal audits and assess in conjunction with QA.
- Assist in developing and maintaining metrics.
Doctorate degree OR Master’s degree & 3 years of engineering and/or manufacturing experience OR Bachelor’s degree & 5 years of engineering and/or manufacturing experience OR Associate’s degree & 10 years of engineering and/or manufacturing experience OR High school diploma / GED & 12 years of engineering and/or manufacturing experience
Preferred Qualifications / Skills / Experience
Why is the Position Open?
- Bachelor's degree in engineering
- 5+ 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
- Understanding and awareness of industry/regulatory trends for verification/validation
- Experience with combination product / medical device quality systems verification
- Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
- Strong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.
- 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
- Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- Proving Process Engineering Experience
- Drug substance experience
- Ability to troubleshoot integrated automated and mechanical system
Employee Value Proposition:
- Plant and Equipment Drug Substance Support
- Reliability Improvements
- Clear communications of issues and resolution plan
Opportunity to join a team with exposure to cutting edge, first product legacy and latest pipeline.
- Poor Communication
- Unable to describe troubleshooting and repair
- Safety not a top priority
Video Skype Panel Interview.
We invite qualified candidates to send your resume to email@example.com
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.