Manufacturing Supervisor, Consumables

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  Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
  

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  Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
  

Job Scope:

The Manager of Microarray Technology will be responsible for:

* Direct oversight of the Array Manufacturing business unit including equipment, people and upstream slide preparation processes.

* Production, production planning and logistics associated with the microarray manufacturing associated with finished products at Luminex

* Accountable to maintain and update manufacturing procedures, worksheets and processes to ensure compliance to cGMP and QSR requirements for microarray manufacturing process at Luminex.

* Technical oversight of Microarray Manufacturing process to ensure compliant manufacturing in cGMP environment inclusive of product configuration management and change introduction.

* Prepare validation or performance qualification protocols for new or modified manufacturing processes associated with microarray manufacturing.

* Hands-on calibration and maintenance, troubleshooting, calibration and repair, on complex microarray equipment.

* Manage outside vendors performing PM's/calibrations on various types of equipment.

* Position facilitates the investigation and resolution of findings identified through audits, non-conformances, corrective/preventative actions, or customer complaints.

Key Duties and Responsibilities

• Train, and develop the microarray team to meet corporate objectives in terms of both Quality and throughput.
• Ensures work in microarray manufacturing is conducted according to approved SOPs
• Reviews and approves DMRs and BPRs, author when applicable
• Responsible for approving in a timely fashion, DHRs for each lot of product produced
• Responsible for authoring equipment validations to ensure all processes and equipment are validated
• Prioritize, schedule, and implement preventative maintenance and calibration plans for microarray manufacturing equipment.
• Ensures microarray technology best practices are adhered to on microarray manufacturing equipment at Luminex.
• Execute equipment qualification protocols and procedures to ensure equipment qualifications meet appropriate domestic and international regulatory agency requirements.
• Write and implement changes to controlled documents (e.g., SOPs, Specifications, etc.) as needed.
• Lead and assist in engineering change control and document change control activities; participate in change control reviews.
• Work cross-functionally with Engineering, R&D, Production Control, QA, Manufacturing Engineering, and Quality Control organizations
• Other duties and special projects as assigned.

Education, Experience and Qualifications

• Bachelor's Degree in Engineering, Industrial Technology, Chemistry, Business or equivalent; required
• 5+ Years related experience and/or training; or equivalent combination of education and experience required
• Basic knowledge of cGMP regulations (21 CFR 820, CMDR and ISO 13485) and thorough knowledge of their impact on manufacturing at Luminex. (High proficiency)
• Computer skills sufficient to maintain effective electronic ERP system and MFG software solution. (High proficiency)
• Ability to read and comprehend complex instructions, procedures and repair manuals (High proficiency)
• Ability and experience in using simple mathematics including performing addition, subtraction, multiplication, and division in all units of measure, using whole numbers, common fractions, and decimals (High proficiency)
• Adaptable, open to change, able to work in ambiguous situations, and respond to new information and unexpected circumstances. (High proficiency)
• Highly organized with proven time management and prioritization skills (High proficiency)
• Ability to handle the pressure of meeting tight deadlines (High proficiency)
• Strong verbal and written communication skills, including presentation and facilitation skills (High proficiency)
• Excellent Project Management skills (High proficiency)
• Ability to handle pressure of meeting tight deadlines and working on multiple tasks at the same time (High proficiency)

Travel Requirements

• 5% Travel may be 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 ofpeople all over the world.