Principal Engineer, Pharmaceutical Processing Equipment

Job Description

Position Summary

Required Competencies: Knowledge, Skills, and Abilities

Advanced knowledge of aseptic filling line technology w/isolators, freeze dryers, formulation equipment, and prep equipment such as autoclaves, parts washers, single use technologies.
Advanced knowledge of equipment control systems.
Advanced knowledge of plant equipment including utilities, HVAC, and facilities.
Strong relationship skills, including the ability to lead/influence people outside of your direct authority.
Advanced knowledge of Project Management principles.
Advanced knowledge of cGMP, GAMP, and OSHA regulations.
Advanced knowledge of regulatory requirements.
Advanced written and verbal communication skills.
Ability to interpret/write complex business documents.
Strong people skills required to work effectively with and support diverse personality types.
Ability to develop, delegate, and motivate others.
Advanced presentation development and delivery skills.
Advanced critical reasoning and decision-making skills.
Ability to facilitate a teamwork environment, delegate appropriately, and motivate others.
Ability to think strategically and be flexible in order to achieve long range objectives.
Advanced knowledge of Microsoft Word, Excel, PowerPoint, and Outlook.
Advanced knowledge of quality control systems, engineering, aseptic design and philosophy.

Key Responsibilities

Responsible for all technical aspects of pharmaceutical processing equipment to be installed and qualified in the Phoenix manufacturing facility.
Responsible for the design, installation, start-up, and qualification of pharmaceutical processing equipment.
After the equipment is installed and qualified for manufacturing use, the position is responsible for the establishment of PMs as well as work with Maintenance to assure the equipment is properly maintained.
Work with Manufacturing on any operational issues or improvements needed as the equipment is put in operation.
Support Maintenance in troubleshooting any related operational issues.

Qualifications & Experience

Bachelor’s degree in an engineering field or other science related field preferred.
7 years of relevant work experience required, preferably in a pharmaceutical or engineering environment.
An equivalent combination of education, experience, and training may substitute.
Advanced knowledge of Aseptic processing equipment.
Advanced knowledge of mechanical, utility, manufacturing, and other plant systems.
Advanced knowledge of quality control systems, cGMP engineering design practices, equipment installation techniques including sustainability opportunities, OSHA regulations, and Factory Mutual requirements.
Demonstrated skills at solving challenging project issues with the ability to develop creative solutions.
Demonstrated project leadership skills and effective decision-making abilities throughout a project while including key stakeholders.

To apply for this job please visit orbiterrecruiting.com.