Engineer Senior - Technical Support GMP Manufacturing (JP12779)

• Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.
• Be individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverables
• Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
• 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 work executed with safety compliant practices and documented in accordance with cGMP good documentation
• Review and approve the commissioning reports, maintenance practices and parts, and drive productivity improvement

• 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 using risk-based approaches
• Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
• Participate in internal audits and assess in conjunction with quality assurance
• Assist in developing and maintaining business metric performance

• Looking for hands on *STRONG* engineer experience with proper training/ background in technical side/ mathematics. (NOT LOOKING for quality lab/ bench top/ science work).
• The job seeker needs to be practical with troubleshooting and be able to hold a technical conversation. Transferrable Industry backgrounds: Drug substance/ pharma / chemical/ oil refinery/ mechanical
• Troubleshooting GMP Manufacturing process equipment.
• Statistical Process Control (SPC), Quality Management Systems (QMS) - Change Control, Project Management, Lean Six Sigma, SOP/Batch Record Development, cGMP Regulatory Compliance, Process Development, Process Validation.
• Bioprocess development and scaleup (cell culture, harvest (isolation), and product assays).
• Process characterization
• Technical writing.
• Tech transfer to cGMP manufacturing and training personnel

• 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.

• Bachelor's degree in engineering or another science-related field
• 7 years of relevant work experience with 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.)

• Resumes should not be brief and have proven documented experience
• Poor Communication
• Poor Leadership
• Poor Teamwork

Salary : $45 - $50