Summary: Performs all tasks necessary for dispensing, preparation, formulation, and aseptic filling manufacturing processes as well as internal labeling packaging and assembly processes. Works individually and as part of a team to operate and maintain highly automated, isolated, filling equipment, assembly and packaging lines. Seeks to understand and develops proficiency in a wide range of processes or procedures of increasing complexity. Applies experience and skills to provide recommendations and solutions, as well as trains and provides guidance to other colleagues.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Operates and monitors a mix of manual and state of the art filling line with isolator technology, as well as formulation and preparation equipment, according to applicable procedures based on training

• Operates and monitors a mix of manual and state of the art, fully automated Assembly, Packaging and Labeling lines according to applicable procedures based on training.

• Operates fully integrated Track and Trace systems on Packaging lines

• Performs line clearance and cleaning activities of preparation, formulation, filling line, assembly and packaging rooms and equipment

• Performs and/or assists with various QC environmental monitoring and product sampling

• Completes and reviews batch records and logbooks in accordance with cGMP standards and compliant with written procedure

• Establishing new procedures and processes required for cGMP production

• Creates, revises and reviews controlled documents

• Executes batch records within the electronic record system (MES)

• Completes training and follows appropriate gowning requirements for cleanroom processing

• Ensures all tasks are performed in a manner consistent with cGMP SOP’s and safety standards

• Coordinates to ensure process areas are stocked with essential equipment and components

• Coordinates with facilities team to ensures equipment and process operational readiness

• Reconciles components and product according to SOP and Batch Record requirements

• Participates in equipment start-up, commissioning, and validation activities

• Performs troubleshooting in case of equipment/systems failure

• Gathers, trends, and analyzes process generated data

• Support investigations associated with process area unit activities

• Maintains and ensures proper documentation of all training

• Responsible for training of new employees

• Assists/contributes in all areas of filling manufacturing, labeling, packaging and assembly as needed

• Travel (domestic and international) may be required to support new equipment purchases and/or training

• Must be able to lift/push/pull at least 40lbs

Knowledge, Skills and Abilities:

• Demonstrated technical aptitude

• Knowledge of cGMP manufacturing environment and familiarity with aseptic processing/filling

• Preferred experience with aseptic technique and operating filling equipment or assembly and packaging of parenteral products in vials, syringes and cartridges using both manual and automated equipment

• Basic understanding of Microsoft Office Suite

• Demonstrates strong interpersonal, cross- cultural, communication, negotiation, and has a high emotional IQ

• Exhibits confidence and strong problem-solving skills and demonstrates ingenuity, creativity and resourcefulness

• Gains understanding from provided instructions and works towards established goals

• Understands and listens to team members and stakeholders’ needs while supporting a positive team environment

• Supports the development and maintenance of a diverse and inclusive environment

Education and Experience:

• To be considered for the Associate Biotech Production Specialist role, you must have one of the following; BS/BA in Life Sciences or related field or AS/AAS Degree/Certificate in Biotechnology/Biological Science, or an equivalent combination of education and experience.