Job Description

• Bachelor's degree in engineering or another science-related field
• 2+ years of relevant work 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
• Demonstrated strong communication and technical writing skills
• Strengths in facilitation and collaboration / networking with cross-functional groups
• 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.)
• Problem solving skills using scientific and engineering methods and investigative skills for root cause analysis.
• Availability to support outside regular hours as needed
  

• Problem solving and applied engineering.
• Basic technical presentations.
• Personal organization.
• Adapting to and managing change.
• Project and document management systems (CDOCS, E-Builder, PCS, BMS and QEMS).
• Validated GMP management systems (Maximo CMMS, Trackwise)
• Project management and cost development
• Conflict Resolution
• Leadership and team building

• Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership)
• Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting safety and quality in their area of work.
• Bachelor's degree in engineering or another science-related field with 2+ years of relevant work experience in operations/manufacturing environment

• 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.
• Lead, evaluate, and manage performance of contract resources.
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Act as a liaison between Engineering, Manufacturing, 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 validation exceptions have been adequately addressed.
• Conduct and document periodic equipment validation reviews.
• Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)
• 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
• 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 risks in conjunction with QA.
• Assist in developing and maintaining metrics related to equipment performance
• Provide technical expertise to develop reliability improvement plan including design requirements, maintenance strategy, spare part procurement.
• Lead improvement implementation plans while following safety requirements
• Assist with equipment maintenance and troubleshooting during project duration
• Contact vendors as needed to understand and assess any change impact (to equip, utility, facility) as improvements are planned and executed.
• Develop GMP documentation following good documentation practices including validation plans and standard operating procedures.

• Must be local- not interested in seeing job seekers who will need to relocate
• Poor communication
• Lack of knowledge on equipment troubleshooting
• Inability to relocate on time
• Inability to speak on responsibilities listed in resume
• Unable to provide occasional afterhours support