Engineer II (Process Engr.)

92081, Vista
Aug 02, 2019
Required Education
Bachelors Degree
Position Type
Full time

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:
  • Experience with Peptides
  • General lab instrument ( GC, FTIR, NMR and KF) knowledge and operation experience

    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.