Manufacturing Technician

Job Description:

Manufacturing Technician

(Clinical Environment)

Ivyland, PA

We are growing and seeking a full time and permanent Manufacturing Technician (Clinical) to join our Team!

Lyophilization Technology, Inc. (LTI), established in 1992, is a unique Contract  Development and Manufacturing Organization (CDMO) enjoying a leadership position in  the health care and related industries.

The company conducts applied research, provides  scientific services and technical support, and manufacturers clinical supplies for freeze  dried pharmaceuticals, biologics, diagnostics, and biopharmaceuticals.

LTI is located in  Ivyland, Bucks County, Pennsylvania. Current operation expansion is underway for 2023  completion.

Our opening for a Manufacturing Technician is an opportunity for a detail  oriented, self-motivated, creative and energetic individual to join a dynamic, technology
oriented organization.

As a member of the scientific team, you will participate in the  preparation of parenteral preparations for clients conducting toxicological and clinical trial  studies.

This unique aseptic processing operation that includes containment capabilities  focuses on preparing sterile lyophilized products for toxicology and clinical studies of
critical freeze dried products.

Collaborating with client project teams, you will be able to  apply your skills and knowledge to the preparation of new and novel lyophilized health  care products ranging from antibiotics to vaccines.

Manufacturing Technician position responsibilities:

Day-to-day operations in the GMP Manufacturing Area, including development  and sterile product preparation.

Procure, and maintain inventory of materials and supplies

Maintain and support an aseptic operation, including cleaning, sanitization  and environmental monitoring activities.

Preparation of sterile toxicology and clinical supply materials.

Be engaged in preparing sterile product, collaborating with other  Manufacturing Technicians, supervisor and Project Director

Participate in batch preparation, fill, lyophilization, inspection and  packaging activities,

Execute procedures for preparation and processing, completing batch  documentation.

Process development and manufacturing techniques for processing, including  sterile products that include cytotoxic, highly potent compounds and biologicals
using isolators.

Work with the supervisor and Safety Officer for sustaining proper  conditions for containment

Compose and review Standard Operating Procedures,

Maintain containment equipment and execute proper procedures.

Equipment Qualification and Process Validation:

Execute validation studies, compile and evaluate data,   Compose validation reports.

Follow all aspects of cGMP compliance for the Clinical Manufacturing Area  including all its related elements such as facilities, equipment and  documentation, training, reports and records.

Work with the Quality Assurance staff on procedures and documentation  associated with production of GLP and cGMP supplies.

We are an Equal Opportunity Employer

We are NOT using search firms to fill this position.

Interested candidates, please submit your résumé along with a cover letter and three (3)  professional references via the MEA.jobs website submission.

For additional information  about Lyophilization Technology, Inc., Please visit our Website at:     https://www.lyotechnology.com/

Experience and Skills:

Requirements:

Seeking a fulfilling growth opportunity

Strong work ethic

Good mechanical aptitude and the ability to troubleshoot on technical and  process related issues preferred

Highly organized with attention to detail for successfully satisfying diverse  responsibilities

Ability to work in a dynamic environment and collaborate with a cross functional  project team

Possess a positive attitude

Excellent written and verbal communication skills

Proficient in MS Windows 10 Pro and MS Office 365 products: Word, Excel,  Access, and Outlook

Ability to routinely lift materials weighing approximately 20 pounds

Possess a valid Driver’s License

Creative problem solving

Preferred Requirements:

1-3+ years of experience in a healthcare product, clinical or commercial  manufacturing environment.

Experience in aseptic processing.

Knowledge of cGMP regulations.

Demonstrated hands-on ability to achieve results in a multi-product environment.

Ability to write investigations and SOPs as needed.

Benefits

By applying your background, knowledge, and experience in our unique technology, within our  internationally recognized organization, you will earn an excellent salary and  comprehensive benefits which include tuition reimbursement, as well as opportunities for  professional development and career growth.