Manufacturing Technician II

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Job Summary

The Manufacturing Technician II (Compound/Fill/Finish) is accountable for results in a fast-paced environment and assists with the manufacturing of sterile injectable products in vial and syringe configurations for clinical/commercial distribution. The Manufacturing Tech II is a key role responsible for executing advanced production tasks involving compound, fill and finish processes for sterile injectable pharmaceutical products executed via aseptic isolator technology. This position entails a high level of technical expertise in aseptic processes requiring single-use components, ability to troubleshoot, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP). The Manufacturing Tech. II performs the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Tech. II employs acceptable techniques while working in manufacturing environments, including PPE gowning. The candidate must have the ability to learn specific department procedures, have a general understanding of Good Documentation Practices (GDP) and GMP, and follow directions from leadership/peers to ensure manufacturing goals are met.

On-Site Expectations

- 100% on-site position.
- 2nd Shift: Monday - Friday, 3:00pm - 11:30pm.

Responsibilities

- Learns and executes manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection.
- Become a subject matter expert (SME) on compounding/filling processes and equipment.
- Performs production processes with adherence to SOPs, batch records, quality standards, and minimally contributes deviations to maintain product quality.
- Conducts in-process and end-of-process sampling/quality checks, ensuring all manufactured products meet rigorous standards.
- Identifies inefficiencies and escalates to area supervision real-time to support continuous process improvement.
- Maintains accurate and detailed production documentation. Documentation is completed legibly with minimum errors and recommendations are escalated to drive document revisions to reduce errors.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Demonstrates technical ability in general manufacturing technologies and utilizes technologies per 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.
- Performs cleaning of rooms, tools, and equipment before and after use.
- 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.
- Follows all Safety requirements and leads by example a safety-first culture.
- Other duties as assigned.

Manufacturing Technologies for Sterile Liquids (including but may not be limited to):

- Equipment and component preparation and sterilization (i.e., filter integrity testing, autoclaving, parts wrapping)
- Compounding
- Vial Washing / Depyrogenation
- Aseptic Filling / Stoppering / Capping
- Lyophilization
- Visual Inspection
- Facility Cleaning/Sanitation
- Documentation Review (Batch Record, Logbooks, etc.)

Qualifications

- High school diploma or GED is required. Associate or bachelor's degree preferred.
- 1-2 years' work experience required; 2-5 years preferred.
- cGMP or prior work experience in a regulated manufacturing environment required.
- Previous experience in dispensing, compounding, aseptic filling, or visual inspection highly desirable.

Knowledge, Skills, and Abilities

- Excellent verbal and written communication skills, works collaboratively in a team environment.
- Proven ability to operate, troubleshoot, and maintain complex manufacturing equipment.
- 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 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 handling requirements (i.e. PAPR, Supplied Air Respirator, etc.).
- General compounding equipment (pH meters, mixers, stir plates, rigid/soft vessels)
- Single-use solution pathway parts including aseptic connectors and filtration assemblies
- Drug Product fillers including isolators
- Strong attention to detail and the ability to detect minute defects or discrepancies in product appearance.
- Excellent communication and interpersonal skills with the ability to effectively train and certify employees.
- Ability to work independently and collaboratively in a fast-paced environment.
- Flexibility to adapt to changing priorities and support operations at variable capacities. Ideal candidates must readily adapt to variable operations required batch to batch.
- Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems is preferred.

Travel Expectations

- Up to 5% domestic travel expected.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, occasionally lift and/or move up to 75 pounds and occasionally lift and/or move over 75 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The employee must have 20/20 vision (with or without corrective lenses) and must possess the ability to pass a color-blind test.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. The use of tight-fitting respirators limits facial hair for proper protection. Based on product, the use of PAPR or supplied air respirator may be required. Regulations may require employees to participate in routine medical surveillance. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle such as a forklift.

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