Engineer II
- Employer
- Bachem
- Location
- 90505, Torrance
- Start date
- Apr 8, 2019
View more
- Discipline
- Engineering, Process Engineer
- Required Education
- Bachelors Degree
- Position Type
- Full time
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Your Responsibilities
- Develop and train employees on utilization of maintenance schedule for new equipment
- Write and assist in composition of instruction and operating procedures of new equipment
- Support projects for facility remodeling and expansion
- Perform activities associated with the design and qualifications of the new and existing equipment used in a manufacturing plant
- Write design qualifications for qualifying batch processing tanks, filter dryers, HPLCs, filtration system, Lyophilizers, cold rooms, ultra-low freezers, HVAC, compressed air, and purified water (experience with cleaning, and automation controls)
- Relies on experience and judgment to plan and accomplish goals
- Create new process and equipment drawings based on specifications and standards
- Update drawings to reflect changes to existing process
- Maintains drawing files (CAD, PDF, and hard copies)
- Oversee the design and construction of new plants
- Troubleshoot process equipment and ensuring that equipment works to its specifications and appropriate capacities
- Draft of new procedures, SOP’s and protocols as well as training of staff for these expectations
- Work with other departments, contractors and vendors
- Perform process development studies for new and existing projects. Write summary reports to support the process development data
- Write standard operation procedures, standard test procedures, master batch records and other related GMP documents
Your Profile
- Bachelor’s Degree in Engineering
- Minimum of 5 years’ relative work experience
- Knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles
- Familiar with pharmaceutical and medical device regulated environment
- Technical knowledge of processes, equipment and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.)
- Experience with Computerized Maintenance Management Systems (CMMS)
- Experience managing projects and providing technical assessments
- Exhibit detail oriented documentation skills, technical writing and SOPs
- May work with hazardous materials and chemicals
- Excellent written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
- Detail oriented with the ability to troubleshoot and resolve problems
- Ability to work independently and manage one’s time
- Communicate effectively and ability to function well in a team environment
Preferred:
We Offer
You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.
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