Equipment Engineering Manager
Newark Metro Area, NJ
Equipment Engineering Supervisor
EDUCATION AND EXPERIENCE
BS in Engineering or Science related discipline preferred.
Minimum 2 years experience in FDA-regulated industry
Experience working directly with biologics manufacturing equipment (Single Use Bioreactors, Chromatography, TFF skids, etc.) preferred.
Knowledge of cGMP in the pharmaceutical industry
Excellent computer skills including knowledge of calibration management and environmental monitoring systems
PURPOSE AND SCOPE OF POSITION:
The Equipment Engineer, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory and clinical manufacturing operations at their home site through interaction with internal team members and internal customers as well as external service providers
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
Strong written and verbal communication skills.
Excellent interpersonal skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
Extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
Working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM.
Ability to interact effectively with laboratory, QA and Facilities groups.