Senior Technician 1, Manufacturing

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POSITION SUMMARY:

The Sr. Technician 1, Manufacturing supports daily manufacturing operations, assigning work, and working alongside team members in the execution of GMP assembly and packaging activities for pharmaceutical combination products. This role brings strong technical expertise, sound judgement, and a solid understanding of cGMP best practices for the assembly and packaging of pharmaceutical products. In this role, the individual will help drive safe, efficient, and compliant production by completing system data entry, maintaining accurate documentation, providing hands-on training, executing production activities, and partnering with support departments across assembly, final packaging, and inspection operations.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Ensure daily production workflows are executed safely, efficiently, and in full alignment with established schedules and daily production goals.
• Supports the team in adapting effectively to shifting priorities, changing production needs, and emerging operational requirements. Adjusting team member duties throughout the day to maintain production levels.
• Responsible for training team members on best practices in the assembly and packaging of products; utilizing (Standard Operating Procedures (SOPs)) to ensure quality requirements are met while maximizing efficiency.
• Ensure all Manufacturing and Quality procedures are adhered to while maintaining Good Manufacturing Practices (cGMP).
• Collaborate with cross-functional teams such as Facilities, Warehouse, Quality, Engineering, etc., to ensure continuous workflow and avoid production downtime.
• Accurately maintain production records utilizing Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP).
• Operate and monitor manufacturing equipment to produce clinical and commercial pharmaceutical products under minimal supervision. Make minor adjustments and input changes via the equipment HMI (Human-Machine Interface).
• Perform the assembly, final packaging, and inspection of pharmaceutical products.
• Possesses strong knowledge of Lean Manufacturing and related principles and can effectively train others in their use.
• Able to take on responsibilities as DEA Monitor.
• Provide input to leadership on employee process and procedural improvement opportunities.
• Perform other related duties as assigned.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• High School Diploma or equivalent

• 2-4 years related work experience; preferably in a medical device or pharmaceutical organization.

• An equivalent combination of experience and education may be considered.

• Skilled in mentoring more junior co-workers, providing guidance and training.

• Ability to clearly communicate and work cross-functionally.

• Ability to recognize issues early and escalate to leadership when needed.

• Ability to troubleshoot issues and implement any needed changes, while communicating timely to the manufacturing team.

• Strong knowledge of Good Documentation (GDP), current Good Manufacturing (GMP) Practices and LEAN Manufacturing methodologies.

• Proven ability to be an effective trainer.

• Must be able to work in a controlled or clean room environment requiring special gowning.

• Proficient computer skills utilizing Microsoft 365, Outlook, and other internal systems.

• Critical thinker with the ability to understand the importance of documentation and data traceability.

• Strong organizational abilities and extreme attention to detail

• Ability to learn new techniques, processes and equipment quickly.

• Ability to plan, prioritize, and manage multiple tasks efficiently.

• Ability to work independently and collaboratively within a team.

• Excellent communication skills, both verbal and written.

• Able to perform physical activity such as standing for long periods of time, walking, and working with hands.

ENVIRONMENTAL CONDITIONS:

Physical Activities: On a continuous basis, be at a desk for a long period of time; intermittently answer the telephone and type on a computer. Some walking and lifting up to 30 lbs. may be required. The noise level in the work environment is usually low to moderate.

The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.

Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.

TRAVEL:

Travel may be required up to 5% of your time.