Job Description

Our Operation Department seeks an Operations Specialist I to play an integral role in maintaining specialized equipment for the manufacturing of tablets, capsules and spray drying dispersion for the use of early phase clinical FDA trials. Operations Specialists are responsible for cleaning, assembling, and system testing equipment; dispensing activities, execution of complex manufacturing processes in a clean room environment, and ultimately becoming a Subject Matter Expert on intricate equipment and processes. The role of an Operations Specialist I at Ser\xc3\xa1n demands an appreciation for and commitment to safety, precision, teamwork, and quality.

Duties and Responsibilities

• Operate specialized machinery to manufacture pharmaceutical products
• Works closely and communicates effectively with operations team
• Develops Good Manufacturing Practice (GMP) skills
• Follow strict standard operating procedures (SOP)
• Safely handle hazardous materials
• Weighs, measures, subdivides, and disposes of components
• Completes documentation, including logbooks and batch production and control records
• Cleans tools and equipment after use
• Maintains equipment
• Ability to wear a Tyvek suit for extended periods of time
• Other duties as assigned

Required Skills and Abilities

• Mechanical aptitude
• Strong verbal and written communication skills
• Strong organization skills and attention to detail
• Proficient math and problem-solving skills
• Strong time management skills with ability to meet deadlines
• Ability to prioritize and ask for assistance to delegate tasks when appropriate
• Ability to focus in a fast-paced environment with shifting priorities
• Proficient with Microsoft Office Suite or related software

Education and Experience

• Bachelor\'s degree in relevant field with 2 years of relevant experience or 4 years of equivalent technical experience in clinical and/or commercial pharmaceutical manufacturing setting
• Minimum of 1 year of GMP experience

Physical Requirements

• Prolonged periods of sitting or standing while monitoring equipment
• Must be able to lift up to 25 pounds regularly, and up to 50 pounds occasionally
• This position has a variety of shift options