Location
Canada | United States
Job description
Reference No. R2731271
Position Title: Filling Technician
Duration: Fixed Term Contract End Date: December 20, 2024
Department: Filling & Packaging Afternoon Shift
Location: Toronto, Ontario
Sanofi Vaccines
Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.
At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
Major Activities of the Job:
Washing & Sterilizing:
R ec e ive goods I it em s f r om t h e w arehouse to be a ut ocl a v e d f o r Filling a c tivit i es.
Ro u tin e l y ta k e WFI, Pu r e St e a m , Co m p r es se d Air Samplings and d e liver to QC
l a b s .
A t t h e e n d of the fill i ng b a t c h disa s s e m bl e , c l e a n , pa s siv a te & s onic a te un i ts.
P r e pa r e e x te nsions, f i lli n g a n d s t op p e ring unit f o r t h e next s c he d u l e d b a t c h.
P e rform T OC a n d Conductiv i ty Test on Un i ts & Perf o rm EMs in W IS area.
P r e pare S t o p p e r ba g s f o r a uto c l a ve
R o u ti ne l y p e rf o rm Audit T ra i l of au tocl a ve r e co r ds.
Wa sh a n d w r a p ha r d goods in p r e pa r a t i on f o r a uto c l a v i ng.
Pri n t l a b e ls f o r a l l pre- au to c l a v e i t em s a n d e nsu r e la b els are a ffix e d on w r a p ped units a n d/or sto p per ba g s pr i or to a u to c l a v i n g.
E n s u r e th er e is adequ a te i n v e n tory to p e r f orm c le ani n g & disinfection and to prepare un i ts f o r filli n g a ctivities.
Saf e ly ha n d l e a cids, det e r g e n ts, cl e ani n g s ol u t i ons a n d W F I as p e r a s our s af e ty
guidelines.
O p e r a te c hart r e c orders (Yok a g a wa a n d Chessell Chart reco r d e r ).
Perform V ac uum Leak a n d Bowie Di c k t e sts a t the beginni n g of each oper a tion d a y pr i or to t h e u s e of the Fe d e gari A u to c l a ve.
Perform fi l t e r i n t egr i ty tests f o r all fi lt e r s used d ur i ng filling a c t i v i t i e s.
P e r f orm p a ssiv a tion of f i lli n g un i t s .
Au to c l a ve ha r d good s , s t opp e rs, a n d c leaning units u s i n g t h e va l id a t e d c y c le of the a u toc l a ve ( F e degar i ).
G en erate e le c tron i c reports for a l l autoclave cycles in th e info tree.
Aseptic Filling Line Set-up :
P r e p are a p prove d c l e ani n g a n d d is in f e c t i o n s o l u t i on s f o r t h e c l e an i n g of the M a t e r i al T r a n s f e r B oo t h ( M TB ) , c an i s t e rs , a n d f i l l i n g machine.
Pr e p a r e a l l p l a t e s a s e p t i c a l l y i n M TB t h a t w i ll b e u s e d d uri n g t h e fi l l i n g process.
S e l ec t required equipment, p ar t s , a n d m a t e r i a l s neede d f o r th e se t u p in G r a d e A R e s tr i c te d A cces s B arr i e r S yste m (RA B S ) a n d doc u m e n t i n t h e B a t c h P roduc t i o n R ecor d ( B P R ) .
Rout i n e l y c h a n gi n g RA B S g l ove s a s o u tl i n e d in t h e r e s pe c t i v e S O P .
As s i s t M ech an i c T e c hn i ci an with t h e re m ov al a n d i n s ta l l a t i o n of vial p o c k e t s d uri n g b a tc h changeover and v e r i fy t h a t t h e f i l l i n g p a r a m e t er s in t h e F il l i n g HMI a r e con sist e n t w i th t h e BP R.
C o nfirm t h e fu n c t i on a l i ty of the in - proces s chec k s t a t i on s ( t are a n d g r o s s ) b y v e rif y i n g t h e tes t w e i g h t s a n d doc u m en t i n g in t h e BP R.
P e rf o rm p r i o r s e t u p d i s inf e c t io n of the f i l li n g m ac hin e .
Se t u p t h e f i ll i n g m ac hi n e u n d e r G r ad e A C l a s s i f i c a t i o n.
Setup the V i al W a s h S t a t i o n a n d D e pyrog e n a t io n tun n e l u n de r Gr ad e D C l a s s i f i c a t i o n .
Pe r f o rm v i s ua l i n s pec t io n a n d pe r f or m d i s in f ec ti o n of the RA B S g l ove s p r i o r t o co m p l e t i o n of the f i l li n g m a c h i n e s e t u p .
As e pt i c a l l y co n n ec t t h e b ulk t ank t o t h e fi l li n g l i n e th r ou g h u s e o f s i ng l e a c t u a t i o ns a s e p ti c c o n n ec t i o n s .
De p e n di n g o n t h e co nf i gu r a t i o n of the b ulk tank, de t e rmi n e t h e u s e o f rec i r cu l a t i o n p u m p s o r pre ss ur i ze d n i t r oge n t o s tart f i l l i n g .
Pe rf o rm re q u i re d e n v i ro n m e n t al m o n i t o r i n g a s o u t li ne d in t h e S O P .
Pe r f o rm dos e c heck s e n s uri n g t h a t t h e f i ll vo l u m e i s c o n s i s t e n t w i th t h e r eq ui r e m e n t s as o u t l i n e d in t h e BP R.
Tr a n s f e r v i al c o m p o n e n t s a n d l oa d i n t o t h e V i al W as h s t a t i o n .
Pe r f o rm E M s in w a s h a r e a .
Loa d Y ok a g a w a C h art a n d C h a s se ll C h art r ec o r d e r in a ti m e l y m an n e r p r i o r t o st ar t i n g setup.
Aseptic Filling:
A l l operators must go wn a s pe r G rad e B c l a ssi f ic a ti o n t o e n te r t h e A s e p t i c
Proces si n g A r e a.
A l l o pe r a t or s oper a t i n g t h e v i al w a s h s t a t io n a n d t h e d e py r o gen a t i o n t u n n e l m u s t b e go w n e d a s p e r G r a d e D c l a s s i f i c a t i o n .
D ur i n g f i l l i n g , pe r f o rm r o u ti n e a n d non-rou t i n e i n t e r v e n t i on s u s i n g t h e RA B S g l ove s as o u t l i n e d i n t h e A s e p t i c P r o ce s s S i m u l a t i o n S t u d y ( A P SS ) e n s uri n g t h a t t h e G r a d e A c a b i n e t i s no t co m p r o m i se d b y t h e G r ad e B s ur r o u n d i n g s .
Pe r f o rm requ i r e d e n v i ro n m e n t al m o n i t o ri n g in t h e G rad e A a n d B r oo m s .
A t t h e e n d of the b a t ch , a s ept i ca l l y d is co n n ec t t h e b u l k tank f r o m t h e f i l l ing li n e .
Pe r f o rm en d of batch e n v i r o n m e n t al m o n i t o ri n g s a m p l i n g .
Cl e ar t h e v i al w a s h st a t i on , d e py r o g e n t i o n tun n e l a n d t h e f i lli n g l i n e o f c o m p o n e n t s .
Disassemble the f i ll i n g l i n e a n d re m ov e i n t erch a n ge a b l e p ar t s f o r c l e an i n g a n d
s t e r i l i z a ti o n .
Complete the p o s t - f i ll d is in f ec ti o n of the v i al w ash , a n d f i l l i n g l i n e .
Environmental Monitoring :
Pe rf o rm e n vi r o n m e n t al ( v i a bl e a n d non-vi a ble ) m o n i to ri n g in As e pti c P roce s s i n g A r e a a n d a d jac e n t roo m s as pe r SOP , w h i c h i n clude s G r ad e A, B , C , a n d D c l a s s if i c a t i o n .
Ens u r e t h a t ea c h s a m pl e i s ide n ti f i e d w i th t h e f o l lo wi n g i n f o r m a ti on:
-D a t e
-T i m e
-I n d i v i du al be i n g s am p l ed
- S a m pl e r
- S a m pl e loc a t io n
Ente r EM s a m ple s i n t o t r ac k i n g d a t a ba s e p r io r t o s u b m i ss i o n t o Q C labs.
De l i ve r E M p l a te s t o Q C l a b f o r incubation.
A d h e r e t o t h e dis in f ec t i o n p r oced u r e w he n t r an s po rt i n g EM m a te r i al th r o u g h d i f f ere n t r o o m c l a s s i f i c a t i o n s .
P e r f o rm rel a t i v e h u m idi ty a n d t e m per a tu r e m o n i t o r i n g t o ens u r e t h a t t h e e n viro n m e n t i s w i thin t h e v a l i d a te d r a n g e f o r t h e f il li n g process.
Cleaning and Disinfection:
Pr e pare cleani n g reagents for re q uired clean in g of t h e As e ptic P r oce ss i n g A r ea a n d a d jace n t r oo m s ( G rade A , B , C , a n d D ) .
E ns u r e t h a t c l eaning e q u ip m e n t are s t e rile and ver i fy t h a t t h e it em s h a ve n o t e x p i r ed pr ior to use.
En s u r e t h a t c l ean i ng is performed from t h e hi gh e s t le v el of classification.
( G r a d e A ) to t h e l ow e s t le v el of c lassific a tion (G r a d e D ).
Per f orm ro u ti n e cleani n g a n d d i sin f e c tion of t h e As e p tic Pr o ces s i n g Area a n d a d j ac e n t roo m s.
D uri n g com m ercial o per a tions perf o rm clean i n g and di s in f e ction of the A P A p r io r t o t h e s ta r t of the f i l l i n g s et u p, af t er t h e co m pleti o n of the f i lling s e tup and a t t h e en d of the f i lling p r oce s s.
W h en RABS glo v es are c ha n g ed e nsu r e t h a t it is cleaned prior to installation.
D i s in f ect B ulk tank during trans p ort f r om F o rmu l a ti o n to F&P and f ro m t h e uncla s sif i ed area i n to t h e fri dg e (G r ade D ) and d ocu m ented in a p p lic a ble BPR a n d logbook.
General Duties:
Pre p a r e m e d i a f o r As e p t i c P r o ces s i n g S i m u l a t i o n S t u d y ( A P S S ) .
Receiv e b ulk t anks f r o m F o r m u l a t i o n s t o Filli n g & Packag i n g a n d m ai n ta i n pr es s ur i z e d syst e m o f t h e t ank i f r e q ui r e d .
M a i n t ain q u a l i f i c a t i o n o f L a bel i n g a n d P a ck a g i n g ac t i v i t i e s in o r d e r t o p e r f o rm jo b d u tie s m L & P in t h e a bsenc e o f F il l i n g O p e r a tion s
Per f o rm f i ll i n g a c t iv i t ie s p e r t a i ni n g t o t h e I S O C e r t if i c a t i o n a n d s m ok e s t u d y .
Complete 5S ac t i v i t ie s o n t h e sho p f l o o r .
T r ain ne w F i lli n g O per a tor s o n t h e s h o p f l oo r .
Minimum Qualifications:
Minimum 2 years College Diploma (Science, Industrial Pharmaceutical) plus a minimum of (1) year relevant work experience.
A s e p t i c P ro c es s in g
cG M P , H e a l t h & S a f e t y.
Aseptic Gowning
Mechanical and Computer Skills
Interpersonal Skills, Communication and Problem-Solving Skills.
Hours Of Work:
Inclusive from Monday to Friday 3:00 pm. - 11:00 p.m.
This is subject to change at any time, and it should not be construed as limiting the right of the company to make such change to meet the requirements of the operation.
Pursue Progress.
Discover Extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at !
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
{For EXTERNAL Postings}
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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