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The Manufacturing Associate performs routine and complex operations for the GMP production of pharmaceutical products. This individual operates in accordance with environmental, health, safety, and cGMP guidelines. This individual is responsible for the hands on execution of production activities as they relate to spray drying, capsule filling, and blister packaging operations of manufactured products.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Performs Clean-In-Place, Clean-Out-of-Place, and equipment sterilization.
- Operates and monitors manufacturing equipment for the production of clinical and commercial pharmaceutical products under minimal supervision.
- Executes routine and complex production processes.
- Troubleshoots manufacturing equipment in conjunction with supporting functional groups to resolve issues and optimize process.
- Performs final packaging and inspection of pharmaceutical products.
- Receives and distributes supplies in the manufacturing area.
- Provides feedback to manager on recommendations for procedural and process improvements.
- Utilizes process knowledge to influence positive change during the review and revision of Standard Operating Procedures (SOPs).
Education and/or Experience:
- A High School diploma or equivalent combined with 5-8 years of experience, or a Biotechnology Certificate or Associate’s Degree in science related field combined with 3-5 years of experience is required.
- A Bachelor’s Degree in Physical or Chemical Sciences (life sciences) or related Engineering field, and a minimum of 1-3 years of experience is preferred.
Supervisory Responsibilities: None
- Experience with operating automated manufacturing control systems is preferred.
- Experience utilizing parts washers and autoclaves for the preparation of manufacturing and/or laboratory equipment.
- Critical understanding of the importance of documentation and data traceability.
- Extensive familiarity with executing Standard Operating Procedures in a manufacturing or assembling environment, preferably in the pharmaceutical industry.
- Strong working knowledge of Good Documentation and current Good Manufacturing Practices.
- Demonstrated ability to perform product and/or process investigations preferred.
Certificates, Licenses, Registrations: None required.
- Must be proficient in MS Office Suite.
- Experience operating automated manufacturing control systems is preferred.
Other Skills and Abilities:
- Demonstrates attention to detail.
- Excellent written and verbal communication skills.
- Ability to multi-task and adjust priorities as necessary.
- Ability to manage both day-to-day operations as well as project work in a fast paced environment.
- Excellent organizational skills.
- Must be able to work well independently and in a team environment.
- Must demonstrate appropriate safety consciousness.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Must have the ability to lift up to 50 pounds.
- Requires physical activity such as standing for long periods of time, walking, and working with hands.
- This position requires minimum travel. Average travel for this position is less than 5% with some variation based upon the demands of business imperatives.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- Must be able to work in a controlled or clean room environment requiring special gowning.
- Must have the ability to work safely and conscientiously in a manufacturing environment.
- Some weekends or holidays may be required.
- May require adjustment to a shift schedule as manufacturing objectives change.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.