Process Development/Validation Engineer LigoCyte Pharmaceuticals
THIS JOB HAS EXPIRED
OBJECTIVES:
(Briefly summarize the overall purpose of the position. Objectives should be written in 3 ? 4 statements).
1. To design and implement manufacturing processes, instrumentation, and equipment from the
laboratory through pilot plant and manufacturing scale up
2. To provide expertise in cell culture, engineering, design, and process and/or scale up
3. To assist the manufacturing operation in problem solving with regard to equipment and systems
4. To develop and recommend new process formulas and technologies to achieve cost
effectiveness and improved product quality
5. To recommend processes for the production of therapeutic products
ACCOUNTABILITIES:
(Describe the primary duties and responsibilities of the job. Approximately 5 ? 10 task statements should be
identified).
1. Responsible for establishing operating equipment specifications and improving manufacturing
techniques
2. Responsible for performing calibration and validation of equipment and systems
3. Responsible for assisting in equipment selection, specifications, and negotiation of competitive
pricing
4. Responsible for maintaining documentation pertaining to qualification and validation
5. Responsible for developing procedures and protocols
6. Responsible for serving as information resource for validation contractors and vendors
7. Responsible for participating in new product scale up, process optimization, technology transfer,
and process validation activities
8. Responsible for interfacing with all applicable departments to ensure processes and designs are
compatible for new product technology transfer and to establish future process and equipment
automation technology.
SCOPE OF SUPERVISION:
SUPERVISED NUMBER OF EMPLOYEES
Direct In-Direct
Managers/Supervisors 0 0
Exempt/Professional/Technical 0 0
Non-Exempt 0 0Job Description Form
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EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
(List the education and experience required to perform the primary responsibilities of the job. Equivalent
combinations of education and experience should be noted.)
? PHD in chemical or bio-chemical engineering, or equivalent
? 2 to 4 years of applicable industrial experience
? Process validation of biological products required
? GMP engineering experience preferred
? Manufacturing of biologics experience preferred
LICENSES/CERTIFICATIONS:
?
?
?
PHYSICAL DEMANDS:
(Identify any unusual physical demands required in the performance of the primary responsibilities of the position).
? Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
? May lift up to 50 pounds
TRAVEL REQUIREMENTS:
(Modify text below as necessary)
? Willingness to travel to various meetings or client sites, including overnight trips. Some international
travel may be required.
? Requires approximately 50 % travel.
| Location: |
2155 Analysis Drive
Bozeman, MT 59718
United States
|
THIS JOB HAS EXPIRED