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

Alcami Corporation•Morrisville, NC

2d•Onsite

About The Position

The Manufacturing Technician I (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. I 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 Technician I 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. I 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.

Requirements

High school diploma or GED is required.
1-2 years’ work experience required.
Prior work experience in a cGMP pharmaceutical manufacturing environment required.
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.
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.

Nice To Haves

Associate or bachelor’s degree preferred.
Previous experience in dispensing, compounding, aseptic filling, or visual inspection highly desirable.
Candidates with NC Bioworks certificate will be considered without manufacturing experience.
Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems is preferred.

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.
Works occasional hours outside of scheduled shift based on business needs, which may include weekend work.
Other duties as assigned.
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.)