Manufacturing Equipment Mechanic

21 hours ago

Sugar Land, Texas, United States QuVa Pharma Full time
About the Role

We are seeking a skilled Manufacturing Equipment Mechanic to join our team at QuVa Pharma. As a key member of our maintenance team, you will play a vital role in ensuring the highest quality and safety standards of our pharmaceutical products.

Key Responsibilities
  • Maintenance and Repair: Perform mechanical and electrical planned and demand maintenance activities on manufacturing equipment in and out of a cleanroom environment.
  • Preventive Maintenance: Perform mechanical and electrical preventive maintenance activities, operational tasks, and troubleshooting on manufacturing equipment in and out of a clean room environment.
  • Equipment Setup and Operation: Set up, run, and maintain manufacturing equipment and assembly processes to make distinct products in a manufacturing environment. Monitor and check the product quality and document results in strict adherence to protocols.
  • Log Maintenance: Maintain a log of activities carried out on equipment, hours worked, spare parts used, etc. using the site CMMS.
  • Independent Judgment: Execute moderately complex assignments and provide independent judgment.
  • Troubleshooting: Diagnose, troubleshoot, maintain, and repair robotic systems, pneumatic and/or hydraulic systems.
  • Production Support: Day to Day coverage of production equipment is assigned area – complete schedule PM's, respond to alarms, solve equipment breakdowns, and fulfill production requests efficiently to minimize downtime.
  • After-Hours Support: Ability to respond to issues after hours and during weekends, with limited supervision.
  • Teamwork: Team player that can operate with other site functions.
  • Maintenance Safety: Follow all aspects of maintenance safety requirements (LOTO, 5S, etc.).
  • Leadership: Exhibits strong leadership skills, such as motivation, delegation, ownership, leading by example, well-developed organizational skills, excellent communication skills.
  • Regulatory Compliance: Comply with 503B guidelines; cGMPs and cGDPs, and company standards.
  • Equipment Interpretation: Interpret equipment blueprints, schematic drawings, and machinery maintenance tasks.
Requirements
  • Education: High School diploma or GED.
  • Experience: 3-5 years of experience working in a manufacturing environment.
  • Regulatory Experience: Experience working in a GMP / FDA regulated industry.
  • Documentation: Understanding of Good Documentation Practices.
  • Maintenance Safety: Experience with Maintenance Safety practices and protocols.
  • Tools and Equipment: Experience using basic hand and power tools, electrical troubleshooting.
  • Equipment Qualification: Knowledge of equipment/utility qualification.
  • Cleanroom Environment: Knowledgeable in ISO 5/7 environment cleanroom gowning.
  • Work Authorization: Must be currently authorized to work in the United States on a full-time basis; QuVa will not sponsor applicants for work visas.
Preferred Qualifications
  • Education: Associate degree.
About QuVa Pharma

QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide.

As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.

We are an equal opportunity employer and are committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. QuVa's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws.

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