Summary Reporting to the Head of Operations MFG11, the Training lead
will play a key role in planning, management, and implementation of
compliance-related and technical training within the Manufacturing
group. This role will act as a key point of contact with the Operations
Department Training team ensuring accuracy and compliance of
Manufacturing training KPIs, training curricula, and records. During our
start-up phase, this role will be crucial in overseeing and ensuring
continuous improvement in the training of new Manufacturing staff in
Bioprocess associate roles. Qualifications \ BSc or MSc in Chemical
Engineering, Bioscience, or Biotechnology. A masters level qualification
would be advantageous. \ More than 8 years in biopharmaceutical
manufacturing, ideally with experience in both upstream and downstream
processing. \ Experience in dealing with FDA, and/or EMA and CFDA, and
have a solid understanding of quality systems in terms of deviation,
investigation, CAPA, and change control. \ Experienced technical
trainer. \ A proficiency in operating a drug substance commercial
manufacturing facility and/or a pilot plant. \ The individual needs to
have a good understanding of DQ, FAT, SAT, IQ, OQ, & PQ (commissioning
and qualification \ Experience with GMP systems such as SAP,
Orchestrate, benchtop equipment, etc. \ A proficiency in operating a
drug substance commercial manufacturing facility and/or a pilot plant.
\ The individual needs to have a good understanding of DQ, FAT, SAT,
IQ, OQ, & PQ (commissioning and qualification). An Equal Opportunity
Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, or protected veteran
status and will not be discriminated against based on disability \ 5
PTO, 5 Sick, 2 Floating Holiday, 10 Paid Holidays \ Benefits begin your
first day of employment \ Health - Cigna \ Dental - Delta Dental \
Life Mart - Employee discounts through ADP \ 401k Retirement Investment
Plan Traditional or Roth - Wuxi Biologics USA LLC matches 100% of the
first 2% of employee contribution and 50% match on the next 4% employee
contribution. Vesting schedule for the company match is 50% after 1 year
of employment and 100% after 2 years of employment. To help you save for
your future, Wuxi automatically enroll employees at 6% (You have 30 days
to opt out of auto enrollment) Click Here To Read Full Job
Description