Senior Manufacturing Engineer

Bend, Oregon /
Operations – Manufacturing /
Full-time Exempt
/ On-site
Serán BioScience specializes in bringing the most challenging drug therapies to market through a comprehensive set of drug-development services and GMP manufacturing. The technical transfer and manufacture of a drug formulation into GMP manufacturing operations is the critical role held by a Senior Manufacturing Engineer. In this role, you will be overseeing the daily support of Manufacturing Operations by facilitating technical transfers from Development and manufacturing of drug product. Being proficient with specialized equipment to help scale-up, troubleshoot and implement efficiencies, and train operations personnel are necessary skills of the role. Strong candidates will demonstrate the ability to communicate effectively with clients and interdepartmental stakeholders, have a proven track record of analytical problem-solving with great attention to detail. Preference will be given to candidates with five years of experience in a pharmaceutical manufacturing environment with industry specific GMP regulatory knowledge. 

Duties and Responsibilities

    • Liaison between Development and Manufacturing for technical transfers
    • Troubleshoot processes and equipment
    • Technical training of operations staff on processes and equipment
    • Optimization of workflow, processes and equipment within operations 
    • Completion of investigation reports, change control and CAPAs
    • Creation and updating of SOPs
    • Writing campaign summary reports 
    • Executes improvement projects
    • Contacts equipment vendors regarding technical issues, service and parts
    • May represent Operations at technical transfer, change control and other project meetings
    • Occasional contract with clients regarding process or equipment related topics

Required Skills and Abilities

    • Strong analytical and problem-solving skills
    • Ability to function well in a high-paced and at times stressful environment
    • Excellent verbal and written communication skills
    • Excellent interpersonal and customer service skills 
    • Ability to interface with clients
    • Excellent organizational skills and attention to detail
    • Proven ability to meet deadlines

Education and Experience

    • B.S or higher degree in a science field
    • 5 years or more working in a pharmaceutical manufacturing environment
    • 5 years of good manufacturing practices for drug products
    • Knowledge of lean six sigma or other preferred

Physicals Requirements

    • Ability to gown 
    • Ability to wear a respirator
    • Prolonged periods of standing on the production floor
    • Prolonged periods of sitting at a desk and working on a computer