Manufacturing Technician II - Sterile Injection - 1st Shift

Alcami Corporation•Morrisville, NC

8d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Candidates with life sciences or engineering degrees will be considered without manufacturing experience.

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.