Manufacturing Associate, Upstream I & II
Company: Randstad Life Sciences
Location: Milford
Posted on: May 12, 2022
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Job Description:
Job Description Job Summary This position is focused on
biologics manufacturing, which includes processing in upstream
(cell culture) and downstream (purification). Operators are
expected to perform these processes while strictly adhering to
cGMP, environmental health and safety guidelines and any other
related regulations which apply. 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 GMP/GDP guidelines.
Troubleshoot process problems and respond to alarms. Provide
information for unplanned events, including entering data into
event management softare. 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 must be worn due to safety requirements. Such additional
responsibilities as the Company may also assign. Qualifications
Level I With high school diploma: Normally requires 0-3 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.
Level II 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.
Company Description Our business is supporting business
productivity, from matching the right people with great jobs to
custom project solutions and consulting. We use innovative
technologies and a passion for people to provide you with the best
experience possible.
Keywords: Randstad Life Sciences, Worcester , Manufacturing Associate, Upstream I & II, Other , Milford, Massachusetts
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