Thrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement. If this describes you, then look no further than LSNE. We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices. Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors.
We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!
JOB SUMMARY
The Manufacturing Technician II proficiently performs a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirement and standards and following all safety guidelines of LSNE. With supervision, the technician performs routine and critical manufacturing operations, including but not limited to work functions in equipment prep, formulation, aseptic compounding, and filling activities for biopharma and medical device products. Works with Master production records and standard operating procedures. Conducts self in accordance with the Guardian values and behaviors.
JOB DUTIES
- Maintains and adheres to safe work habits and all applicable LSNE safety procedures and guidelines
- Proficient execution and knowledge of aseptic techniques
- Prepares solutions, aseptic filling and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation and sterilization
- Assembles, disassembles and operates aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled non classified environments. Operates vial capper, unloads product from lyophilizers and liquid fill line.
- Prepares equipment and components for sterilization and Lyophilization
- Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation, centrifuges, mills equipment.
- Assists in the formulation and dispensing of product in a clean room environment per SOPs and MBRs
- Sanitizes production areas and prepare equipment for production
- Completes and maintain documentation related to assigned work, including logbooks, batch records, etc.
- Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
- Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations
- Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs
- Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations
- Reviews and revises pertinent SOPs and production batch records as required
- Inspire and constantly strive to make LSNE a great place to work and respected for the quality of its people and products and clients
- Successfully participates in media fill/aseptic proficiency test
PROFESSIONAL SKILLS -
- Ability to weigh and measure raw materials and operate basic Benchtop instruments (move to physical?)
- Able to follow written instructions. Seeks help with more complex and non-routine tasks
- Skilled at organizing and prioritizing assigned tasks to assure completion
- Can translate ideas on how to improve work tasks
- Strong verbal and written skills
EXPERIENCE -
- 2 -4 years of working experience, preferably in a manufacturing environment ideally in the pharmaceutical or medical device industry. Fill finish experience, preferred.
EDUCATION
- Requires AA degree with 0-2 years' experience or high school diploma with 1-3 years related manufacturing experience or Associates Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Biotech Certificate and 1 year of experience
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.
https://www.applicantpro.com/j/1725907-36199
