Manufacturing Associate III-Downstream
Posting ID: JP-001969241
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.
Demonstrate procedures as a part of training sessions for other team members; may schedule
o 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)
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
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.
Gmp, Batch record, Microsoft office, chromatography, autoclave, media preparation, buffer preparation, Production, Cleanroom
Top Skills Details:
1. Purification Manufacturing
3. Microsoft Office Suite
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Sean Davis
Phone: (781) 356-6917