Category: Engineer

Employment Type: Contract To Hire

Reference: BH-373304

Yoh is hiring an LSM Equipment Engineer to join our client working towards buliding a sustainable pipeline of potential therapies, leveraging translational medicine and data analytics to achieve the best outcome. The LSM Equipment Engineer will support the successful operation of laboratory and clinical manufacturing operations. Aditionally, the LSM Equipment Engineer will be responsible for initiating and owning deviations, CAPAs, change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations.

Location: Warren, NJ
Type: Contract to Hire (Fully on Site)
Compensation: $40-50/hour DOE


Responsibilites:

• Executes equipment calibration, preventative maintenance, performance verification and repair activities in laboratory and manufacturing areas.
• Supervises vendors for calibration, preventative maintenance, performance verification and repair functions.
• Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness.
• Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
• Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20C / -80C Freezers), Incubators, Cryotanks, and Cryopods).
• Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.
• Authors and supports the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment.
• Support the development, review and approval of calibration and maintenance plans in site CMMS system.
• Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards.
• Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available.
• Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed.
• Approves Change Request, Asset Inductions, Work Request, as well as Calibration and Maintenance forms.
• Perform NCRs investigations.

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment.
• Knowledge of calibration management and environmental monitoring systems.
• Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
• Strong multitasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously.
• Proficiency in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications.
• Working knowledge of scheduling software and systems, and inventory management systems, Blue Mountain RAM and Maximo preferred.
• Environment may include working in office, laboratory, or manufacturing area.
• Wearing proper gowning and/or PPE such as safety glasses and shoes in an environment with hazardous materials and waste will be required.
• Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 lbs.
• Ability to sit, stand, walk, and move within workspace for extended periods as well as ability to perform repetitive tasks, including hand to finger manipulations, grasping, pushing, and pulling.

• BS in Engineering or Science related discipline required.
• Minimum 3 years of experience in FDA-regulated industry.
• Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.)
• Maintenance coordination/planning experience preferred.
• Experience working in a clinical environment preferred.