Upstream Manufacturing Associate III (Contract - Sun-Wed, 7a-5:30p Shift)

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.
• Monitor and record batch parameters, including computer data entry.
• Complete relevant paperwork following GDP/GMP guidelines.
• 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.
• 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.
• Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, chromatography skids and columns, analytical equipment.
• 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.
• Lead team meetings and facilitate multidepartment discussions.
• Additional responsibilities as the Company may also assign.

Qualifications

• With high school diploma: Normally requires 3-6 years of related experience required or an Associate’s Degree in Life Sciences/Engineering field. Biotech Certificate preferred.
• With Bachelor’s degree: Normally requires 1-4 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.
• Able to write 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.
• Good interpersonal skills and be 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.

Physical Requirements

• PPE as required.
• May require lifting amounts of 25 lbs.
• Manufacturing operations tasks requires operator to regularly remain on feet for shift.