Manufacturing Technician III - Sterile Injection - 12-Hr Night Shift 2-2-3

Responsibilities

• Performs complex manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection.
• Serves as a subject matter expert (SME) on compounding/filling processes and equipment, providing guidance and training to other manufacturing employees.
• Maintains quality and compliance with Good Manufacturing Practices (GMP) by monitoring production processes, conducting in-process and end-of-process sampling/quality checks, and making real-time adjustments to maintain product quality.
• Troubleshoots and resolves complex equipment and process issues, minimizing downtime and ensuring efficient production flow.
• Collaborates with cross-functional teams on continuous improvement initiatives to enhance product quality, safety, and efficiency.
• Assists with the validation and qualification of new equipment and processes, ensuring seamless integration into the production workflow.
• Maintains accurate and detailed production documentation, adhering to SOPs and cGMPs.
• Performs in-process sampling, weight checks, and component counting and basic math calculations.
• Performs in-process inspection and finished product visual inspection.
• Assists with other manufacturing areas as required.
• Performs activities right first time in areas of material handling/dispensing, compounding, and filling.
• Follows general instructions on routine work and detailed instructions on new projects or assignments.
• Fulfills occasional hours outside of scheduled shift based on business needs, which may include weekend work.
• Performs other duties as assigned.

Qualifications

• High school diploma or GED required.
• Associate’s or Bachelor’s degree preferred.
• 4-6+ years of relevant experience required, with a strong background in sterile/aseptic manufacturing or Drug Substance manufacturing.
• Prior work experience in a cGMP pharmaceutical manufacturing environment required.
• Prior pharmaceutical or CDMO experience required.
• Knowledge, Skills, and Abilities: Capable of executing tasks with minimum oversight while giving guidance to team to ensure manufacturing success; excellent verbal and written communication skills; proven ability to operate, troubleshoot, and maintain complex manufacturing equipment; demonstrated leadership skills, with experience training and mentoring team members; strong analytical and problem-solving skills with a focus on detail and accuracy; applies job skills, company policies and SOPs to complete a variety of assignments; strong detail orientation and organizational skills required; strong problem-solving and basic trouble-shooting ability required; ability to train others effectively; ability to perform basic math calculations; ability to read and comprehend detailed written instructions and apply instructions during execution is required; ability to move materials throughout the facility using appropriate methods and equipment required; ability to use the appropriate PPE based on product (i.e. PAPR, Supplied Air Respirator); basic computer skills (Microsoft Office) and familiarity with electronic documentation systems is required.