Position Overview:
The Manufacturing Equipment Mechanic is responsible for maintaining and repairing manufacturing equipment in both Controlled Non-Classified areas and in Classified clean room environments within the pharmaceutical manufacturing facility. The position operates within legal and regulatory compliance, ensuring systems are maintained and operating according to site and regulatory requirements; capable of following procedures, documenting work as/when performed and maintaining a clean/organized workplace supporting site compliance and upholding quality standards.
Responsibilities may include:
- Perform mechanical and electrical planned and demand maintenance activities on manufacturing equipment in and out of a cleanroom environment
- Perform mechanical and electrical preventive maintenance activities, operational tasks, and troubleshooting on manufacturing equipment in and out of a clean room environment
- 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
- Maintain a log of activities carried out on equipment, hours worked, spare parts used, etc. using the site CMMS
- Able to execute moderately complex assignments and provide independent judgment
- Diagnoses, troubleshoots, maintains, and repairs robotic systems, pneumatic and/or hydraulic systems
- 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
- Ability to respond to issues after hours and during weekends, with limited supervision
- Team player that can operate with other site functions
- Follow all aspects of maintenance safety requirements (LOTO, 5S, etc.)
- Exhibits strong leadership skills, such as motivation, delegation, ownership, leading by example, well-developed organizational skills, excellent communication skills
- Comply with 503B guidelines; cGMPs and cGDPs, and company standards
- Interpret equipment blueprints, schematic drawings, and machinery maintenance tasks
Qualifications:
- Legally authorized to work in the job posting country
- High School diploma or GED. Associate degree preferred
- 3-5 years of experience working in a manufacturing environment
- Experience working in a GMP / FDA regulated industry
- Understanding of Good Documentation Practices
- Experience with Maintenance Safety practices and protocols
- Experience using basic hand and power tools, electrical troubleshooting
- Knowledge of equipment/utility qualification
- Knowledgeable in ISO 5/7 environment cleanroom gowning
To be considered:
To be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.
JOB DESCRIPTION &
REQUISITION APPROVAL
Personnel Requisition Form.doc.rar ` 11/15/23
Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.
It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
Job Type: Full-time
Pay: $28.26 - $35.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: In person
