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Company Contact Info
- Santa Ana, CA
- Alexandra Luhrsen
- Phone: 7144812119
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Aerotek • Santa Ana, CA
Posted 1 month ago
Looking for a Production Engineer in Orange County! Direct Placement! APPLY TODAY
Bachelor of Science in Engineering, Chemistry or related field degree.
1 -5 years relevant industry experience.
Experience with regulated industry Product Development and Regulatory requirements.
Familiar with Chemistry, Engineering and Manufacturing operations.
Knowledge of state, federal, and international regulatory requirements and submissions (Federal marketing application such as NDA, ANDA, IND, PMA, etc…) for Pharmaceutical (or medical device) products.
Knowledge of FDA requirements (cGMP and marketing applications)
Support both processes development and product development for generic sterile injectables
Prepare engineering documentation for equipment procurement (e.g. URS, DDS, FAT, SAT) as well as equipment installs (e.g. IQ, OQ) and process validations (e.g. Cleaning Qualifications, Process Qualifications)
Develop and define product specifications, procedures, and controls.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.