Responsibilities Include:

Perform operations according to Standard Operating Procedures (SOP's)
Perform and monitor critical processes, execute routine validation protocols and regularly
draft and revise documents such as Manufacturing Procedures, SOP's and technical reports.
Conduct basic troubleshooting and assist in the review of documentation for assigned
functions.
May participate on cross-functional teams and represent the manufacturing teams.
May also be responsible for owning deviations/CAPA's.
Identify, recommend and implement improvements related to routine functions.
In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (C
or D Shift). This includes extra benefits such asreceiving an added 15% shift differential, and
also getting premium pay for any Sundays worked.The schedule during the initial on-boarding
phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately
8am to 5pm).

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The
hard-working professional we seek is a committed team player with these qualifications.

Basic Qualifications:
High school/GED + 2 years of manufacturing or operations work experience OR
Associates + 6 months of manufacturing or operations work experience OR
Bachelors
Preferred Qualifications:
Bachelor's degree in Science or Engineering
Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic
processing, etc.
Knowledge of Single-use Systems
CFR and Regulatory knowledge
Mechanical ability/expertise
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
Demonstrated technical writing capability
Able to demonstrate project management skills and presentation skills
Ability to understand, apply and evaluate basic chemistry, biology and physical principles