Duties and Responsibilities Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities). o Operate manufacturing process equipment to perform various manufacturing production steps. o Knowledge on initiating new revisions for procedures. o Proficient operating inside of a BSC, sampling, and performing with aseptic techniques. o Monitor and record batch parameters, including computer data entry. Complete relevant paperwork following GDP/GMP guidelines. o Troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software. o Order, receive and distribute supplies into production area as needed. Convey information to external stake holders (auditors, global colleagues, etc.). Provide support for groups that support manufacturing. Participate on Continuous Improvement Teams. May perform other duties as assigned. (During Production Processing these activities may increase) o Manufacturing operations tasks requires operator to regularly remain on feet for shift. o Pushing buffer containers ranging from 50L to 200L. o Sitting for periods of 2 to 3 hours. o Demonstrated knowledge of CGMP manufacturing. o Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment. o Proficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement, and military time. o Able to read and follow detailed written instructions and have good verbal/written communication skills. o Able to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms. o Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.) o Good computer skills, knowledge of Microsoft Word, Excel. o Good interpersonal skills and be able to work effectively and efficiently in a team environment. o Ability to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule. o Ability to work in a clean room environment and comply with hygiene standards and use of special garments. Additionally, personal protective equipment must be worn due to safety requirements.
Qualifications With high school diploma: Normally requires 1-4+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred. With Bachelor's degree: Normally requires 0-2+ years of related experience. Good with Microsoft Office Outlook, Word, Excel.
Seniority level
Entry level
Employment type
Contract
Job function
Research, Analyst, and Information Technology
Industries
IT Services and IT Consulting
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