Engineer II, Facilities BSD

Employer
Bachem
Location
Vista, CA, US
Posted
Nov 08, 2020
Ref
624813301
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Your Responsibilities

The Engineer II will be responsible for providing engineering and technical support to Manufacturing, Information Technology, Quality, Engineering, and the Operations departments toward sustaining, improving and optimizing maintenance operations. Functional areas of operation include all production unit operations in weighing and dispensing, buffer preparation, media preparation, fermentation, filtration, chromatography and lyophilization. The Engineer will support our Vista site with their knowledge and experience working under cGMP/cGLP requirements.

Your Tasks
  • Work closely with Facilities and Operations in support of trouble shooting of process equipment, asset replacement assessment or any pertinent technical support
  • Apply knowledge of measurement science, mathematics, physics, and electronics to calibrate inspection, measurement, and test equipment (IM&TE) in the electrical, dimensional, optical, physical, mechanical, environmental, and/or chemical disciplines to ensure measurement accuracy
  • Provide technical assessments for preventive maintenance, investigations, validation and change control
  • Manage corrective actions as a result of investigations
  • Play a leadership role in the start-up and troubleshooting of process equipment and critical clean utility systems
  • Review and provide recommendations on design drawings, which may include PFDs that incorporate P&IDs, which include all the sizing, instrumentation and control philosophies
  • Interact with vendors concerning contracts of significant financial value and select vendors based on the most appropriate combination of price, quality and delivery. Review and approve vendor information packages, including drawings and specifications
  • Generate controlled documents to support start-up, operation, validation and maintenance of equipment and systems
  • Perform calibration and repair of advanced analytical instrumentation used in biopharmaceutical manufacturing processes and QC laboratories
  • Perform diagnostics, repairs, and modifications of advanced industrial process control instrumentation
  • Implement corrective and preventative actions pertaining to analytical and process instrumentation issues that directly impact manufacturing systems availability
  • Prepare and organize technical documentation and operational procedures from equipment manufacturers, equipment users, and engineering personnel
  • Inspect new instrumentation installations by contractors and affect necessary changes to comply with established departmental standards
  • Install, test equipment, operate and maintain equipment for manufacturing and in-process testing. The equipment includes analytical HPLC and prep HPLC system, lyophilizers, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and others used in manufacture
  • Write Standard Operation Procedures, Standard Test Procedures and other related GMP documents. Will include some technical writing
  • Follow and maintain GMP Documentation System. Investigate any process deviation, write process deviation report, and initiate document change request
  • Identification of process bottlenecks and vulnerabilities
  • Project management, obsolescence mitigation (risk assessment) and equipment specifications
  • Contractor management and supervision

Your Profile
  • Bachelor's Degree in Chemistry, Chemical Engineering, Mechanical Engineering, Automation Engineering or Manufacturing Engineering.
  • Minimum of 5 years' relative work experience
  • May work with hazardous materials and chemicals
  • Knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles
  • 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
  • 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

l looking for a new challenge and want to join a motivated team in an internationally renowned company,

you should seize this opportunity.

Nearest Major Market: San Diego