Medical Engineering Consultants (MEC) ยท 2 months ago
Technical Transfer Process Engineer
St. Louis , Missouri
Full-time
Onsite
Senior Level
7+ years expMedical Engineering Consultants (MEC) support medical device and pharmaceutical companies to enhance efficiency and productivity. The Technical Transfer Process Engineer will be responsible for supporting technical transfer projects for pharmaceutical and biological drug products, including designing experiments, authoring protocols, and analyzing complex data.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Act as key technical lead for process development
Independently design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer
Independently design studies for evaluating the robustness of the manufacturing process. These studies will serve as a baseline for the further process validation activities
Independently evaluate process data and perform in-depth analysis using scientific principles for evaluation of critical process parameters governing the performance of the process. Exercises judgement in selecting methods, techniques and evaluation criteria
Represents Tech Transfer department as subject matter expert routinely in meetings/conference calls with clients
Works with client's lead technical staff, department management and senior management to evaluate complex technical details pertaining to the project and defines the scope of the project
Makes recommendations to the business development team regarding pricing and project studies and assist in preparation of project proposals
Function as the Subject Matter Expert (SME) for Manufacturing processes and Technical Transfer of new products in regard to process development
Collaborate with analytical, production, quality and project management team and ensure timely completion of project deliverables
Independently review and analyze complex process data from the clinical and commercial manufacturing batches for conformity and facilitate batch release
Works independently and provide guidance to lower-level personnel or as a team member
Execute QbD (Quality by Design) experiments to support the development and characterization of new manufacturing processes
Independently manage multiple cross-functional projects that may require regulatory submissions
Effectively present complex technical information to guide decision making
Independently author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc
Provide technical support for fill finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization
Perform periodic review of processes/systems
Write and revise SOPs and Master Plans
Apply CGMP and CGDP to all areas of work
Support the development of manufacturing production records and protocols for execution in support of qualifications, developmental/technical transfer projects, or for clinical and commercial manufacturing
Provide training to managers and production/laboratory staff for protocol requirements and new manufacturing processes
Work with individuals at all education/experience levels and with multiple departments (production, laboratory, engineering, materials management, etc.)
Qualification
Required
B.S. in Science or Engineering with a minimum of 7 years of equivalent job experience
Strong leadership skills; high level of personal/departmental accountability and responsibility
Strong understanding of process design principles
Experience with drug product manufacturing processes development, process scale-up and optimization
Ability to perform well under tight timelines and excellent decision-making quality under pressure is desired
Ability to manage multiple priorities and tasks in a dynamic environment
Excellent written and communication skills
Data evaluation and interpretation, including statistics and process controls
Experience and knowledge of sterile processing principles (aseptic or isolator technology)
Ability to exercise judgment to determine appropriate corrective actions
Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions
Ability to work in a team environment with multiple departments and experience/educational levels
Proficient knowledge of CGMP
Coordinate multiple tasks simultaneously
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.
Founded in 2011Fort Lauderdale, Florida, USA
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christopher Gustine
Managing Partner
David Campo
Managing Partner
Company data provided by crunchbase