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Pharmaceutical Manufacturing Specialist
2 months ago
Experic is a premier contract development and manufacturing organization (CDMO) specializing in clinical trial supply services. Our mission is to provide innovative and scalable solutions throughout the product life cycle, from clinical trials to commercial production. We utilize advanced pharmaceutical manufacturing, packaging, and labeling technologies to accommodate various dosing and packaging formats. Our commitment to precision, state-of-the-art filling equipment, and compliance with Class A regulatory standards ensures the successful execution of our clients' pharmaceutical development programs.
We are dedicated to cultivating a team culture rooted in trust, integrity, ethical conduct, and compliance, with a steadfast focus on delivering high-quality outcomes. At Experic, we promote a collaborative work environment that values open communication and continuous improvement. Here, you can build a rewarding career, engage in meaningful work, and experience personal and professional growth. We seek candidates who bring unique perspectives and expertise while embodying our core values.
Key Responsibilities:
- Operate pharmaceutical manufacturing equipment in a GMP environment to produce clinical supplies and conduct development experiments. Lead manufacturing activities in designated production areas.
- Comply with and understand all policies and procedures at Experic, including regulatory standards, safety protocols, SOPs, and work instructions.
- Assist in developing new processes and procedures under management guidance, including:
- Becoming a subject matter expert on pharmaceutical manufacturing equipment.
- Translating equipment knowledge into new SOPs and work instructions and training additional staff on equipment usage.
- Conducting frontline troubleshooting of processes and equipment.
- Perform pharmaceutical manufacturing tasks, including:
- Batch documentation and record generation.
- Materials sampling, staging, dispensing, and returns.
- Setting up, operating, and cleaning pharmaceutical equipment and rooms.
- Utilizing appropriate personal safety equipment and engineering controls.
- Conducting in-process inspections and sampling.
- Using the Experic IT platform.
- Support developmental manufacturing experiments as directed by management.
- Assist with investigational and quality systems activities.
- Collaborate with maintenance on preventative maintenance, troubleshooting, and equipment repairs.
- Engage in continuous improvement initiatives at Experic.
Additional Requirements:
- Adhere to all federal and state regulations and guidelines.
- Follow all company and site policies and procedures.
- Possess mechanical aptitude and a curiosity for complex machinery, with a desire to learn new processes.
- Demonstrate the ability to learn and remain self-directed on both well-defined and exploratory tasks.
- Stay current with industry trends and developments.
- Contribute positively by suggesting improvements and acquiring new skills and procedures.
- Be available for additional duties and overtime as needed.
Supervisory Responsibilities:
- None.
Qualifications:
A bachelor's degree in an Engineering or Scientific field with three years of experience in the Pharmaceutical or Life Sciences sector, or a High School Diploma with seven years of experience in Pharmaceutical manufacturing, focusing on new equipment and process implementation.
Language Skills:
- Ability to read and interpret documents such as standard operating procedures, manuals, batch records, and specifications.
- Communicate effectively in writing and orally, including the creation of standard operating procedures and work instructions.
Mathematical Skills:
- Apply basic arithmetic concepts to practical solutions.
- Graph data using spreadsheets and perform simple statistical analyses.
Reasoning Ability:
- Identify and solve simple to moderate problems related to job functions.
- Utilize scientific reasoning to gather data, formulate hypotheses, and draw conclusions systematically.
- Apply deductive and inductive reasoning to solve complex problems.
Other Skills and Abilities:
- Knowledge of cGMP and familiarity with Pharmaceutical Manufacturing.
- Complete regulatory and job training requirements successfully.
- Proficient in data entry and word processing software.
- Ability to perform repetitive tasks while maintaining speed and attention to detail.
- Work effectively both independently and in a team environment.
Physical Demands:
- Frequent standing, walking, and using hands to handle or feel objects.
- Occasional sitting and reaching with hands and arms.
- Ability to lift and/or move up to 50 pounds preferred.
- Specific vision abilities required include close vision, distance vision, and depth perception.