Aseptic Process Engineer ll
Aseptic Process Engineer ll
Location near Taylorville, IL
Industry: Pharmaceutical / Biotech
Job Category: Engineering? Process
Full-time Benefits - Full
Relocation Assistance Available ? Yes
Interview Travel Reimbursed - Yes
Visa Candidate Considered: Yes
The process engineer with a passion for Operational excellence and process improvement. Must thrive in fast-paced environment. The process engineer will provide technical engineering expertise for standardizing and improving existing processes, play a key role in new product launches, be responsible for leading the successful implementation of multiple initiatives for the development, design, validation and project management of pharmaceutical manufacturing processes including new equipment procurement through installation, process conversions, process equipment lifecycle, all that meet Quality and Regulatory compliance requirements of pharmaceutical operations.
Supporting and troubleshooting day-to-day operations, capital projects, and pipeline products in aseptic manufacturing processes.
Engineering and process optimization for aseptic manufacturing processes and related operations.
Perform financial analysis activities to determine project cost savings and ROI.
Assess current processes to reduce processing times and reduced utility consumption by measuring KPI.
Performed process design improvements to reduce the quantity of lost batches and improved quality of products.
Delivers strategic and technical expertise to drive continuous process improvement that generate cost savings and optimize efficiencies.
Assist with design of new facilities and systems from conceptual design, specifications, budgeting, scheduling, and construction management.
Develop documents for FAT/SAT activities for process equipment.
Participate in FAT, SAT, the startup and commissioning of process equipment after design phase.
Provided direction to contractors to meet project schedule and financial goals while ensuring technical success.
Participate in procurement efforts for process and facility related equipment and facilitate change orders during the project.
Drive remediation work for design improvement or correction for process equipment and processes.
? Bachelordegree, Chemical Engineering, Engineering, or Pharmacy degree.
? 5years of experience in process engineering in a pharmaceutical or similar manufacturing environment.
? 3+ years of aseptic manufacturing processes
? Knowledge and experienced with generic, sterile injectable and ophthalmic.
? Experience in process development, experimental design/statistical analysis, process optimization, and scale-up.
? Experience in new product introduction, technology transfer, and process/equipment validation.
? Working knowledge of various manufacturing processes and unit operations including, vial filling, sterilization formulation, and secondary packaging.
? Knowledge of process automation/control systems.
? Continuous improvement Lean Manufacturing/Six Sigma/OE tools and techniques.
? Understanding GMP Documentation as it relates to the job function
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.