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Manufacturing Technician II

2 months ago

Durham, United States Alcami Corporation Full time
Job Summary:

The Manufacturing Technician II - Visual Inspection Specialist is accountable for results in a fast-paced environment and is responsible for maintaining product quality by supporting visual inspection and GMP operations of life-saving sterile injectable drug products intended for clinical trials and commercial distribution. The Manufacturing Technician II operates in alignment with established Standard Operating Procedures (SOPs) and approved Batch Records, which are developed in accordance with regulatory expectations and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician II employs acceptable cleanroom techniques while working in inspection/manufacturing environments and is expected to demonstrate proficiency in all department procedures and provide manufacturing updates to area supervision.

On-Site Expectations:
  • 100% on-site position.
  • 2nd Shift: Monday - Friday 3:00pm - 11:30pm.
    • Shifts may include weekends and holidays to support operations, as necessary.
Responsibilities:
  • The primary role is to perform visual inspection of syringes, liquid vials and lyophilized products to identify potential defects or discrepancies in product appearance and container integrity.
  • Follow established SOPs and cGMPs to execute protocols and procedures for visual inspection, ensuring compliance with regulatory requirements and company standards.
  • Conduct visual inspection training to support employee qualification, and to ensure consistent and accurate inspection practices across manufacturing shifts.
  • Maintain defect kits and defect libraries to support process qualification and general improvement.
  • Sample and package finished product batches for further testing and analysis, ensuring proper documentation and labeling.
  • Maintain unit accountability throughout inspection/manufacturing operations and provide batch yield reports to area management.
  • Manage inventory of batch consumables and finish product samples, retains, and acceptable units for further processing.
  • Other duties include, but may not be limited to the following:
    • Provide general support for dispensing, compounding and isolator filling operations within Grade C/D environments to assist operations in varying capacities.
    • Support operations through area sanitization, equipment preparation, and performing in-process testing such as pH testing, glove/filter integrity testing, etc.
    • Collaborate with cross functional teams to address quality related issues and implement process improvements.
Qualifications:
  • High school diploma or GED is required. Associate or bachelor's degree preferred.
  • 1-2 years work experience required; 2-5 years preferred.
  • Previous experience in visual inspection of syringes, liquid vials or lyophilized products is highly desirable.
  • cGMP or prior work experience in a regulated manufacturing environment required.
  • Prior pharmaceutical or CDMO experience required.
  • Prior Standard Operator Procedure author experience is highly desirable.
Knowledge, Skills, and Abilities:
  • General knowledge of current Good Documentation Practices (GDP) and ability to legibly document activities performed in real time per area SOPs.
  • Familiarity with PDA Technical Report No. 43 is highly desirable.
  • Experience with any of the following equipment is highly desirable:
    • Light inspection booths, light meters and TAPPI charts.
    • Filter integrity testers, steam sterilizers (autoclaves).
    • 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 a plus.
Travel Expectations:
  • Up to 5% domestic travel.
Physical Demands and Work Environment:
  • Visual acuity and color vision are essential for accurately identifying defects and discrepancies in product appearance.
  • Employees are regularly required to stand for extended periods while performing inspections and/or supporting manufacturing operations.
  • Job may require repetitive manipulations while handling syringes, vials and lyophilized products.
  • Ability to lift up to 10 pounds frequently and occasionally lift/move up to 50 pounds (with assistance).
  • Technicians must have good manual dexterity and hand-eye coordination to work safely within a GMP manufacturing space.
  • Area sanitization requires the use of disinfectants and sporicides.
  • Visual inspection and operational support occur in cleanrooms and controlled manufacturing environments. This may include exposure to wet and/or humid conditions with moderate noise level at times. Work areas remain well-lit with proper ventilation and temperature control to support operator comfort and maintain product quality/integrity.
  • Technicians may be exposed to pharmaceutical products, chemicals, and potentially hazardous substances with the use of personal protective equipment such as face masks, Powered Air Purifying Respirators (PAPRs), and Supplied Air Breathing Respirator (SABRs) with necessary training and medical evaluation.