Job Scope
The person in this role will be responsible for assisting in setting the daily priorities, and task delegation with the team members. They will participate in the manufacturing processes to support new product design transfer, stability program, process development, equipment validations, process validations and investigations and resolution of product/process issues for Microarray area. They will setup production equipment, prepare raw materials for production, and verify the correct amount of materials to complete the production run successfully. In addition, they will partner-up with other individuals to cross-train team members and share knowledge.
Key Duties and Responsibilities:
Assisting in setting the daily schedule, priorities, and task delegation.
Supervise and setup machines (microarrayers, change over, troubleshooting, reject/defective products for daily operations to run and produce products.
Monitor team members for quality production output using PLC controls, routine quality inspection checks, integrity testing, visual inspections etc.
Monitor number of rejected product for defect during quality check and notify management team.
Performed data entry into the ERP (Oracle and Oracal) on regular basis.
Follow work instructions, product specifications, standard operating procedures (SOPs) to perform key responsibilities and maintain quality data.
Utilize lab equipment such as pipettes, centrifuges, Bio-safety cabinet (BSC) and degas system to provide material to run Microarrayers.
Share knowledge and lead trainer of co-workers/new hires (where applicable).
Perform Equipment preventative maintenance as required.
Perform quarterly maintenance activities (such as cleaning the cleanrooms)
Follow the designated GMP (Good Manufacturing Practice), Safety, and Personal Protective Equipment (PPE) standards.
Properly handle and discard hazardous materials (i.e., Glass, Buffers, chemicals etc.)
Follow daily and weekly lab cleaning routines (utilizing 5S).
Meet daily production goals and minimize downtime.
Effectively communicate with management team and Maintenance functions (where applicable)
Participate and attend department and company meetings.
Adherence to attendance policy
Other duties as assigned.
Qualifications:
Bachelor's degree in science or engineering/technology required.
4+ year(s) of relevant industryexperience in medical technology manufacturing or related industry required including GMP (Good Manufacturing Practice) /GDP (Good Documentation Practice) environment.
2+ years in a leadership role/project management role.
Ability to follow instructions, written and verbal.
Solid computer skills - ability to navigate through software applications.
Excellent time management, change management and detail orientation skills.
Experience with Robotic/Technical/Precision equipment preferred.
Standard Physical Demands
Standing - Frequently
Stooping - Occasionally
Bending - Occasionally
Climbing - Occasionally
Sitting - Occasionally
Kneeling - Occasionally
Lifting upto 40lbs - Occasionally
Travel Requirements
0% No travel is required.
What We Offer
Receive a competitive salary and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world.