Top Biopharma/ CDMO* client is hiring!! Looking for Manufacturing associates who specialize in both UPSTREAM AND DOWNSTREAM PROCESS DEVELOPMENT.
*Contract Development and Manufacturing Organization (CDMO)
- 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)
- 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.
- Demonstrated knowledge of CGMP manufacturing.
- Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment.
- 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.
- Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
- 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.
- Ability to work in a clean room environment and comply with hygiene standards and use of special garments. Additionally, personal protective equipment
- Experienced in GMP downstream manufacturing; especially with TFF, Chromatography systems and purification of Mabs
- Specific equipment/systems that we are using include; Akta ready, Akta Process , XDUos buffer systems and disposable technology systems
- Must have experience with troubleshooting of the equipment and of process and excellence in clinical manufacturing
- Other possible responsibilities may include writing deviations/investigations and revising batch records if needed.
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
Aerotek is acting as an Employment Agency in relation to this vacancy.
Posting ID: 582784965Posted: 2020-10-28