Principle Engineer, Aseptic Processing Equipment
Pharmaceutical / Biotech Industry
Location near Taylorville, IL
Full-time /Benefits/Competitive Salary
Relocation Assistance Available - Yes
Bonus Eligible - Yes
Interview Travel Reimbursed - Yes
• The Principle Engineer, Aseptic Process Equipment will have primary responsibility for providing technical ownership for the design, selection, and support of equipment, technologies, and systems used to manufacture and package aseptic products.
• Needed to have experience working in the aseptic pharmaceutical manufacturing setting with demonstrated success in a cross-functional team environment.
• Must have sterile injectable generic medication as well as ophthalmic products such as Thera Tears experience.
• This role includes collaboration with site and global manufacturing, finance, engineering, IT and quality functional resources.
• Coordinate and conduct aseptic equipment engineeringrisk assessments and execute improvement plans for new and existing systems.
• Participate in cross-functional investigations on problems/deviations including defining corrective and preventative actions.
• Support Maintenance in advanced troubleshooting of aseptic equipment issues.
• Provide designs and recommendations for aseptic equipment upgrades and retrofits to remediate known challenges or improve equipment performance.
• Develop aseptic engineering standards in conjunction withinternal/external stakeholders.
• Good written and verbal communication skills to interact with internal and external personnel providing timely information to avoid production delays.
• Develop training material and standards on aseptic engineering requirements and provide the necessary coaching and training to personnel along with the upskilling of existing personnel.
• Contribute in FAT’s, SAT’s and design reviews.
Qualifications/ Ideal Candidate
• Bachelor of Science (BS) in Chemical or Mechanical Engineering from an accredited college.
• Minimum of 7 years of experience in the traditional clean room aseptic pharmaceutical industry.
• Must have sterile injectable product manufacturing experiencerequired.
• Experience with Validation Lifecycle Documentation required.
• Experience with the design, specification, and troubleshooting of aseptic process equipment is required.
• Aseptic process equipment maintenance experience is required.
• Process control system & automation experience (SCADA/MES/PLCs) is required.
• Experience with RABs is required.
• Technical training in aseptic building design is beneficial.
• Packaging equipment experience is beneficial.
• Excellent communications skills in oral, written, and presentation situations providing clear, informative, and persuasive communication in positive and negative scenarios.
• Good analytical and computer skills required.
• Willingness to Travel – Occasionally
Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.