Engineer Principal, Biotechnology JP

Engineer Principal, Biotechnology

3 Key Consulting is hiring an Engineer Principal for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Reporting to the Director Physical Sciences and Engineering, Manufacturing Sciences and Technology (MSAT), the successful candidate for this position will manage (projects, personnel, and laboratory) an engineering group responsible for development of innovative solutions to complex biotechnology device and packaging problems based on insightful interpretation and analysis of the problem statement or investigation. These key activities serve MSAT in the development of physical methods, characterization studies, and design verification deliverables for CPO.

The principal engineer will operate in a highly matrixed environment to collaborate effectively with cross functional teams. The principal engineer is responsible to critically analyze department requirements, ensure documentation and laboratories maintain proper state of qualification, calibration and preparedness for inspections related to safety, compliance and procedures. The principal engineer must also clearly communicate and elevate technical or strategic issues to team members and management as needed and make robust recommendations and/or decisions to guide successful execution of mechanical testing for primary containers, device and packaging test methods.

Group members within the functional area look up to this position as a scientific/technical expert who can provide guidance on associated issues as needed. Demonstrated supervisory skills are required.

Responsibilities include managing a team to:

• Own and maintain business processes for development, qualification, validation and transfer of physical test methods for product verification of new products, and transfer of validated methods to client supply chain, Quality, or manufacturing labs at all client sites. The principal engineer must ensure documentation can withstand an audit and pass agency scrutiny.
• Develop and own Standard Operating Procedures for data creation, storage, retention, and audit in accordance with Title 21 CFR Part 11 Compliance for all lab testing and associated 21
  
  CFR 820 requirements for device development.
• Rapidly design, develop, qualify, and innovate automated inspection equipment for client primary containers and devices to meet new and unique product requirements.
• Work with Device Technologies to advance state of the art physical methods and other emerging technologies to characterize, evaluate, and release combination products, primary containers, and secondary packaging. The candidate is expected to support input data solutions going into Device Master Records and associated work product with clinical and commercial manufacturing for combination products, primary containers, and secondary packaging.
• Design, develop and execute mechanical testing using phase appropriate controls for the development and qualification of primary container platforms and medical devices to develop specifications.
• Facilitate communication with client sites and vendors to establish user requirements for the characterization of primary packaging components used in the commercialization of drug products and devices
• Work closely with facilities, maintenance, instrumentation, and electrical systems to ensure laboratory equipment is maintained in compliance with all industry, regulatory, corporate, and regulatory standards. Ensure laboratory compliance for quality audits utilizing internal and external calibration laboratories, vendors and suppliers.
• Advise others on methods of resolving measurement problems. Keep current with information from other industry experts through participation in government and industrial standardization committees and professional societies

Top Must Have

Skills:

• Technical writing experience - minimum 2 years
• Experience with regulated industry
• Pharma, Biotech, preferred
• Experience with managing projects and teams
• Masters, PhD degree, Bachelors with minimum 8 years

Day to Day Responsibilities:

Own and maintain business processes for development, qualification, validation, and transfer of physical test methods for product verification of new products, and transfer of validated methods to client supply chain, Quality, or manufacturing labs at all client sites. The principal engineer must ensure documentation can withstand an audit and pass agency scrutiny.

Basic Qualifications:

Doctorate degree and 2 years of engineering experience, OR

Master's degree and 6 years of engineering experience, OR

Bachelor's degree and 8 years of engineering experience, OR

Associate's degree and 10 years of engineering experience, OR

High school diploma / GED and 12 years of engineering experience

AND

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Degree in Engineering, MBA or related field
• 8+ years of…