The Qualification Engineer III is a professional who understands and provide technical expertise in the manufacturing process, site facilities and utilities. He or she is responsible for designing, developing and maintaining robust qualification system in order to fulfill Noven Pharmaceuticals, Inc. standards and procedures, regulatory requirements and cGMP regulations and guidelines. Oversee the design, implementation and qualification of new technology for manufacturing processes, site utilities and facilities. Responsible for executing multiple projects, on both a large and small scale, sustaining commercial activities and/or product development projects with a vision of a quality by design culture and continuous improvement. Assists manufacturing operations, quality, facilities and utilities teams in troubleshooting and problem solving with regards to materials, components, equipment and systems. Develops and recommends technologies to achieve cost effectiveness, improved product quality and reliability. Recommends processes for the production of therapeutic products using tankage, piping, coating /oven systems, laminating dies, pouching machines, packaging, facilities and utilities (compress air, chillers, cooling towers, HVAC, etc.) systems.
Education & Experience:
BS in Mechanical, Electrical, Industrial or Chemical Engineering or a related engineering discipline with 5-9 years of experience and/or training; Experience in the pharmaceutical or medical device industries (preferred). Must possess the solid understanding of engineering fundamentals, engineering best practices, troubleshooting methodology, project management, process-utilities equipment qualification. Enhance knowledge of cGMPs, pharmaceutical / medical device manufacturing methods, and validation principles.
Good written and oral English communication skills. Computer literate a must, strength with Statistics used for Design of Experiments as well as MS Project and AutoCAD required. OEE (Overall Equipment Efficiency), Certified Lean Six Sigma, TQM, Project Management experience for executing smaller tasks, small-medium projects and initiatives. Experience with Business and Technical systems such as TrackWise, Master Controls, JDE, Minitab, and AutoDesk Vault a plus. Good written and oral English communication skills.
Judgment / Decision Making:
Self-starter and must be able to work with minimum supervision. Works on complex problems of diverse scope where analysis of data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Work will often be performed within a cross functional framework and will involve the development and writing of quality policies, procedures, etc. A high degree of original thinking, resourcefulness and networking will be required to coordinate projects or solve problems.
Responsibilities for Contacts:
Frequent internal contact with all levels and functions of personnel. Contact with vendors, customers, contractors, partners, and Health Authority Inspectors during audits/inspections to exchange information, coordinate projects, and negotiate solutions.
The ability to work in and communicate well within a team structure in multiple projects, thrive in a fast-paced environment and adapt to changes with a positive attitude is required. Must be able to work in a fast paced environment, and have excellent communication and emotionally intelligence skills.
Time distributed between office and Product Development / Operations / Facilities / Utilities environment with exposure to moving parts, mechanical rooms and noise.
Regularly stands for more than two hours at a time, with some stooping and bending. Visual acuity and manual dexterity required to operate computer, and proofread documents.