- Developing, writing, and completing various quality systems and safety documentation such as:
- Standard Operating Procedures (SOP), Change Control (CCMS), Non-Conformance (NC), Work Orders (WO), Job Plans (JP), Hazard Risk Assessments (HRA), Job Hazard Assessments (JHA), etc.
- Responsible for various aspects of building, utility and production systems/equipment
- All work must be completed in a safe (in accordance to HRA, JHA, etc), timely manner according to planning and predefined schedules with minimal impact to production while complying with Good Manufacturing Practices (GMP), SOP, Code of Federal Regulations (CFR).
- Interact with peers and clients in manufacturing, maintenance, utility plants, analytical labs and contracted services.
- Provide training for staff, clients and projects, audit support, reviews and technically approves maintenance reports, forms, plans and records, develops, revises, and reviews equipment, maintenance or other related procedures
- Interpret and revise loops sheets, electrical schematics, P&ID's, I/O wiring and panel drawings
- Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
- Required to know, comprehend, and apply packaging configurations, as well as understand, follow and document batch records for the inspection and packaging process.
- Reconcile components and products, and calculate product exposure to room temperatures;
- Filling and finishing manufacturing experience, preferably vial inspection;
- Understanding of measurements, calculations and the metric system
- Basic GMP knowledge
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Senior Maintenance Technician - Thousand Oaks, United States - AstrixTechnology LLC
Description
Job Description
Job DescriptionOur client, a renowned leader in the field of biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines
Title: Sr. Maintenance Technician
Location: Thousand Oaks, CA
Pay: $25-29/hr
Contract to hire
In this role, you will be expected to work a 12-hour shift (6:30PM-7:30AM), Thursday through Saturday, and alternating Wednesdays. The schedule during the initial on-boarding/training phase (2-6 weeks) will be Monday through Friday, approximately 8am to 5pm
Day To Day Responsibilities:
The Sr. Maintenance Technician role will be responsible for performing advanced installation, troubleshooting, maintenance, repair, testing, and documentation/logs of a wide variety of office utility and facility equipment used in manufacturing, utility plants, analytical labs, and office areas.
Responsibilities include:
Basic Qualifications:
Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.
Company Description
Since 1995 Astrix has been delivering information technology consulting, regulatory advisory services and staffing solutions to the scientific community. We can assist in augmenting your internal resources to deliver optimum solutions on time and within budget. It is our goal to simply do it right. We work everyday to create value and build trust with our clients, employees, partners and vendors.\r\r
Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.
