Upstream Manufacturing Associate III (Overnight Pitman)

Duties And Responsibilities

• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities).
• Operate manufacturing process equipment to perform various manufacturing production steps.
• Knowledge on initiating new revisions for procedures.
• Proficient operating inside of a BSC, sampling, and performing with aseptic techniques.
• Monitor and record batch parameters, including computer data entry. Complete relevant paperwork following GDP/GMP guidelines.
• Troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software.
• Order, receive and distribute supplies into production area as needed.
• Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers.
• Participate in (and may lead, as requested) team meetings and facilitate multidepartment discussions.
• Convey information to external stakeholders (auditors, global colleagues, etc.).
• Provide support for groups that support manufacturing.
• Participate on Continuous Improvement Teams.
• May perform other duties as assigned.

Qualifications

• With high school diploma: Normally requires 7+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred.
• With Bachelor’s degree: Normally requires 4+ years of related experience.
• Good with Microsoft Office – Outlook, Word, Excel.