06 October 2021
Manufacturing Process Engineer – Biotechnology

Manufacturing Process Engineer - Biotechnology
Miami, Florida
 
 
Background
Our client is a leader in the Biologics industry, and it is considered to be a trailblazer in the R&D arena.   It has engaged ttg Talent Solutions  to find their next Manufacturing Process Engineer.  If you meet the requirements and like to be part of the spear’s head of this industry from tomorrow today, please consider applying.
 
Description
The Process Engineer I is responsible for evaluating and improving manufacturing processes to reduce cost, improve yields and reduce variation. This position performs equipment qualifications and process validations. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to manufacturing from R&D. Process Engineer I makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above.
 
Duties and Responsibilities
  • Generate and execute protocols to perform equipment qualifications and process validations.
  • Use LEAN Manufacturing principles to analyze processes and make recommendations for improvements.
  • Lead efforts to solve problems using formal problem resolution techniques and root cause analysis.
  • Create and communicate project plans with detailed tasks and timelines necessary for project completion.
  • Develop equipment and process validation protocols (IQ, OQ, PQ) and reports.
  • Lead and perform equipment qualifications and process validations as needed.
  • Develop and monitor process and equipment metrics to use for optimization analysis.
  • Other duties as assigned.
 
Qualifications
  • Bachelor’s degree in Biomedical Engineering or other applicable engineering discipline.
  • 1 – 3 years of experience in Tissue Banking, Device, Biologics, or Pharmaceutical industry in a relevant engineering role.
  • Strong analytical, planning, project management, critical thinking, troubleshooting, and problem-solving skills.
  • Ability to effectively communicate with multidisciplinary teams.
  • Excellent technical writing.
  • Preferred: Strong knowledge of LEAN Manufacturing principles.
  • Preferred: working knowledge of 21 CFR 1271 regulations and AATB guidelines.
  • Proficient in project planning software. Microsoft Project preferred.
  • Knowledge in CAD software preferred.
 
Responsibilities
  • Creating and revising in-house SOPs for validations, IQ/OQ/PQs and process improvements.
  • Writing and executing the qualification and validation of equipment and processes used by Recovery and Processing Personnel under cleanroom conditions.
  • Optimization of freeze drying cycles to increase output capacity and overall efficiency for the birth tissue product line.
  • Process mapping to identify areas of improvement and implement new process procedures to reduce cost and increase productivity.
  • Worked on improving the process of the labeling and packaging of products.
  • Project leader on cleanroom cleaning validation, antimicrobial effectiveness studies, and bio-burden studies.
  • Space analysis to better optimize the space for various departments within the facility.
  • Experience with CAPAs, Customer Complaints, and NCRs.
  • Change Control engineering re presentative for documents related to validation protocols and equipment.
  • Coordinated new device transfer from R&D stage into productions.
  • Create project plans to ensure on-time completion of projects.
  • Project Manager for implementation of new microbiology culture methods with an outside microbiology lab, static mitigation in cleanrooms, autologous tissue process optimization.
  • Project lead on cleanroom, environmental monitoring, cleaning and processing validation.
  • Experience with aseptic techniques, root cause analysis and effective problem solving.
  • Project Manager of remediation projects for FDA and AATB audit responses
 
 
 
 
 
 
 
 
At ttg, We believe in making a difference One Person at the Time,” ttg OPT.