Sr. Manufacturing Tech – 2nd Shift – Aseptic Filling
- Location: Morrisville, NC
- Type: Direct Hire
- Job #35280
Hours: Monday – Friday, 3:00pm – 10:30pm
The Senior Manufacturing Technician is accountable for results in a fast-paced environment and is responsible for manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Senior Manufacturing Technician operates manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Senior Manufacturing Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Senior Manufacturing Technician demonstrates proficiency in all department procedures, trains and coaches other technicians, and provides work instruction and oversees daily work assignments in the absence of the supervisor as needed. The Senior Manufacturing Technician interacts with customers as needed. The position requires superior leadership behaviors of the companies core competencies and non-negotiables, as well as expertise in functional competencies for the role.
- Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Performs and oversees applicable manufacturing techniques and technologies per SOPs and cGMPs.
- Performs and oversees manufacturing technologies and operation of manufacturing and material handling equipment.
- Documents activities in real time on controlled documentation and legibly, per SOPs and cGMPs.
- Performs in-process testing, weight checks, component counting and basic math calculations.
- Performs cleaning of rooms, tools and equipment.
- Demonstrates proficiency in all department procedures and trains and coaches other technicians.
- Provides work instruction and oversees daily work assignments in the absence of the supervisor as needed.
- Assists with other manufacturing areas as required.
Manufacturing Technologies for Sterile Liquids:
- Equipment and component preparation and sterilization
- Aseptic filling
- Visual inspection
Education and Experience
- High school diploma or GED with 5 years of related experience required.
- cGMP or prior work experience in a regulated environment required.
- Prior pharmaceutical or CDMO experience required.
- Consistently demonstrates honesty and integrity through personal example.
- Follows all safety policies and leads by example a safety first culture.
- Produces high quality work product with a focus on first time right.
- Complies with the company code of conduct and policies and regulatory standards.
Core Leadership Competencies
- Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
- Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
- Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
- Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
- Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
- Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
- Excellent verbal and written communication and documentation skills required.
- Excellent detail orientation and organizational skills required.
- Excellent problem-solving and basic trouble-shooting ability required.
- Ability to perform basic math calculations.
- Ability to read and comprehend detailed written instructions required.
- Ability to move materials throughout the facility using appropriate methods and equipment required.
- Proficiency in basic computing skills required.
- Ability to train, coach and develop others required.
- Prior experience with cGMP practices and procedures required.
- Proficiency in aseptic processing and manufacturing operations using filling machines, filtration equipment, autoclaves, and semi-automatic inspection machines
- Ability to develop and optimize processes, procedures, and the agility to change directions when required