Downstream Manufacturing Associate I (Contract)

Wed-Sat 4/3 Day Shift, 6a-6:30p

Duties and Responsibilities

• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities).
• Operate manufacturing process equipment to perform various manufacturing production steps.
• Knowledge on initiating new revisions for procedures.
• Proficient operating inside of a BSC, sampling, and performing with aseptic techniques.
• Monitor and record batch parameters, including computer data entry. Complete relevant paperwork following GDP/GMP guidelines.
• Troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software.
• Order, receive and distribute supplies into production area as needed.
• Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers. Participate in (and may lead, as requested) team meetings and facilitate multidepartment discussions.
• 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)
• Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, chromatography skids and columns, analytical equipment.
• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
• Such additional responsibilities as the Company may also assign.

Qualifications

• With high school diploma: Normally requires 1+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred.
• Good with Microsoft Office – Outlook, Word, Excel.
• Proficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement, and military time.
• Able to read and follow detailed written instructions and have good verbal/written communication skills.
• Able to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms.
• Good computer skills, knowledge of Microsoft Word, Excel.
• Good interpersonal skills and be able to work effectively and efficiently in a team environment.
• 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

Working Conditions

• Personal Protective Equipment must be worn as required
• May require lifting amounts of 25 lbs.
• Manufacturing operations tasks requires operator to regularly remain on feet for shift.
• Pushing buffer containers ranging from 50L to 200L.
• Sitting for periods of 2 to 3 hours.
• 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.

Physical Requirements

• PPE as required.
• May require lifting amounts of 25 lbs.
• Manufacturing operations tasks requires operator to regularly remain on feet for shift.