Contract Manufacturing Operator
- Davis Dr, Morrisville, NC, USA
Liquidia Technologies is a biopharmaceutical company transforming the development of new therapies by precisely engineering drug particles. Our proprietary PRINT technology is a simple, elegant solution that solves common problems with drug delivery and efficacy. PRINT technology is a scalable cGMP compliant process that creates particles and can apply to virtually any therapeutic area, molecule or route of administration. Liquidia is bringing more efficient, controlled development capabilities to the industry while enhancing the safety and quality of products for patients. Liquidia is advancing product candidates from its own pipeline. These initial product candidates, LIQ861 and LIQ865, apply the PRINT technology to better drug delivery in inhaled and pain therapeutic areas, respectively. The PRINT technology is also licensed with world-leading pharmaceutical companies that are developing future product candidates.
The Manufacturing Operator will support all GMP manufacturing activities by providing daily cleaning and maintenance of manufacturing cleanrooms. This position is responsible for performing and documenting routine cleaning activities and providing support for manufacturing operations. The operator will work with the Manufacturing Operations team to ensure a 1st class manufacturing organization to drive the Company’s programs to commercial success while ensuring the highest level of quality and safety standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Perform routine cleaning activities of room and equipment, such as daily, weekly, bi-weekly, monthly, biannual and annual cleanings; in addition to any remedial cleanings that may be needed inside a controlled Cleanroom environment under the supervision of Manufacturing Operations staff.
- Responsible for waste disposal, preparation of cleaning agents, and room and equipment cleaning to support manufacturing activities.
- Provide basic support to manufacturing runs including material handling, and inventory management including restocking supplies.
- Learn basic manufacturing operations activities to assist the Senior Manufacturing Technicians and Engineers during production runs, including support of manufacturing line changeovers, equipment setup and others.
- Follow and adhere to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) to maintain clean and clear documentation on the cleaning and equipment logbooks, Batch Production Records (BPR) and other required documentation.
- Perform all tasks in compliance with relevant SOPs, environmental health and safety guidelines, FDA regulations and any other related regulations which could apply.
- Participates in both departmental projects and any quality working teams which may be applicable; under the general direction of the Senior Manufacturing Technicians and the overall direction of the Manufacturing Operations Manager.
- Must be willing and able to work 1st shift: 7:30am-4:30pm, Monday through Friday
- Must be able to speak, read, write and follow detailed written and oral instructions in the English language.
- Must have good written and oral communication skills and understanding of compliance with current Good Manufacturing Processes (cGMP) regulations.
- Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment.
- This position may require 2nd shift and weekend work.
- Must work in a clean room environment, wearing special garments; additionally, personal protective equipment must be worn due to safety requirements
- Personal protective equipment must be worn due to safety, cGMP and FDA requirements
EDUCATION and/or EXPERIENCE
- Associates degree with 0-3 years of manufacturing experience or High School Diploma with 2-5 years of manufacturing experience in Medical Device, Pharmaceuticals and/or Biotechnology industry.
- Hands on experience in a cGMP manufacturing environment is a must.
- Experience with cleanroom operations and cleaning preferred.
- A positive attitude, teamwork and attention to detail are key to success in this position.
- Must be able to lift, push, pull and/or carry up to 50 lbs.
- Repetitive motions with hands, wrists, turning head, bending at knees and waist.
- Must be able to work in controlled environments requiring special gowning;
- Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body,
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- May work in a cold environment
- Must be able to work multiple shifts, including weekends
- Must be able to work overtime as required, including Saturdays
All your information will be kept confidential according to EEO guidelines.