Senior Project Engineer
Description
INCOG BioPharma Services is seeking a Sr. Project Engineer who will have expertise in the management and engineering support for projects. Responsible for supporting design, construction, CQV and start-up activities. This position must be able to seamlessly work with A&E, General Contractors, OEMs, and Suppliers to provide unified engineering solutions. Additionally, author project documents, equipment impact assessments, root-cause analysis reports, technical reports, and provide technical assessments, rationales and approval for engineering and changes as well as documentation pertaining to process utilities and equipment to meet regulatory requirements.
Essential Job Functions:
• Work closely with design teams to assure equipment and process reliability.
• Prepare and conduct initial training for new equipment/systems.
• Monitor and analyze project performance to maintain Key Project Indicators, KPIs
• Participate and support equipment/process FMEAs to understand process and product risks.
• Participate and report to a cross-functional team to advance project activities.
• Participate in Operational Excellence activities within Tier Structure.
• Ensure successful project execution by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and start-up issues.
• Lead and ensure systematic DMAIC based approach utilization for equipment /process related investigations to identify root cause and provide impact assessment to maintain routine project activities and determine process improvements.
• Develop project and technical documentation (PEP plan, RFPs, equipment specifications, schedules, project reports, calibration program, preventative maintenance plans and procedures).
• Work with vendors and suppliers to define requirements and understand functional specifications
• Work flexible hours for the coverage of project demand.
• Other duties as assigned.
Special Job Requirements:
• Practical expertise with GXP manufacturing, Plant/Clean utilities, and regulatory requirements for pharmaceuticals and EHS&S bodies.
• Demonstrated knowledge of project management and project controls tools.
• Knowledge of data management tools and RCM.
• Bachelor’s degree in engineering field, biochemical engineering, biotechnology, or life sciences
• 8+ years of relevant work experience
Additional Preferences:
• PE or PMP certification
Additional Information about INCOG BioPharma Services:
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
By submitting your resume and details, you are declaring that the information is correct and accurate.