Downstream Manufacturing Associate III (Contract - Wed-Sat 4/3 Overnight Shift, 6p-6:30a)

About the role

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals.

Responsibilities

• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities).
• Strong knowledge and understanding of manufacturing process and equipment to perform various production steps.
• Ability to train employees.
• Maintain and record batch parameters, including computer data entry; complete relevant paperwork following GDP/GMP guidelines; perform mathematical calculations related to production processes.
• Initiate new documents for procedures; may make minor revisions to existing documents.
• Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies.
• Identify and troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software.
• Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution.
• Order, receive and distribute supplies into production area as needed.
• Pushing buffer containers ranging from 50L to 200L.
• Sitting for periods of 2 to 3 hours.
• Convey information to external stakeholders (auditors, global colleagues, etc.).
• Support groups that support manufacturing (such as external cleaners, etc.).
• Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.).
• Provide knowledge in areas of training process improvements.
• Such additional responsibilities as the Company may also assign.

Qualifications

• With high school diploma: 6+ years of related experience required or an associate degree in Life Sciences/Engineering field; biotech Certificate preferred.
• With Bachelor’s degree: 4+ years of related experience.
• Demonstrated knowledge of cGMP manufacturing.
• Knowledge of laboratory and pharmaceutical production equipment.
• Able to read and follow detailed written instructions and have good verbal/written communication skills.
• Able to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms.
• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.).
• Good computer skills, knowledge of Microsoft Word, Excel.
• Able to work effectively and efficiently in a team environment.
• Ability to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule.
• Ability to work in a clean room environment and comply with hygiene standards and use of special garments; additionally, personal protective equipment must be worn due to safety requirements.