Engineer II (Process Engr.)

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.