Equipment Engineer, ECQ
Edison-New Brunswick Metro Area, NJ
The ECQ Equipment Engineer supports the successful operation of facility, laboratory and business functions at their home site through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. The incumbent may be asked to lead small to medium sized projects in their area of responsibility, and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit. The incumbent will be involved with writing deviations, investigations and supporting the implementation of change controls.
Education, Knowledge, Skills & Abilities:
BS in Engineering or Science related discipline preferred.
Minimum FIVE years of experience in FDA-regulated industry preferred.
FOCUS ON candidates with good solid qualification/validation background who ALSO have a strong background/experience in the following
---- Risk Management
---- Analytical Method Development
---- Deviation/ Investigation
---- Change Management
---- Corrective Action Management
---- SOP development/ review
---- CTU Mapping
---- Process development of Immunotherapy products
Note: You might look for engineers who were previously in validation work transition to QA (or vice versa) to have this type of background.
MORE KSA s:
Instrumentation background and experience in laboratory and manufacturing operations.
Knowledge of cGMP in the pharmaceutical industry.
Excellent computer skills including knowledge of calibration management and environmental monitoring systems.
Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
Minimum 2 years of maintenance coordinating / planning experience, preferably in a laboratory environment.
Experience working in a commercial environment preferred.
Experience writing and supporting deviations and investigations preferred.
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.
Strong multi tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Highly proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
Working knowledge of inventory management systems (CMMS), mainly Blue Mountain RAM.
Ability to interact effectively with laboratory, QA, and Facilities groups.
Physical / Mental Demands:
Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
Ability to sit, stand, walk and move within workspace for extended periods
Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
Will likely spend ?70% of their time in a laboratory or manufacturing environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
Ability to work safely and effectively when working alone, or working with others.