Pfizer
Assistant Manager - MSAT Process Engineering Bachelors or Master’s in
engineering / Pharmacy
Knowledge
& Skills:
Expertize
in Process Engineering aspects related to sterile drug product / injectables
manufacturing
Working
experience in TS equipment train i.e Formulation process equipments,
automation, Filling, and Terminal sterilization.
Good
knowledge on pharma equipment and its engineering aspects.
Problem
solving skills
Process
analytical skills
Hands
on experience leading the investigations independently.
Yellow
belt certification is a must. Candidates who were trained and working for M2
project will be preferred.
Soft
skills:
Good
Communication & Presentation Skills
Effective
negotiation and Interpersonal Skills
Leadership
skills
Responsibilities:
To
Provide technical support for the equipment technologies during technology
transfer.
Technical
support for Investigations and CAPAs for Process equipment.
To
ensure and adhere the Pfizer EHS requirements for safety at the work.
To
lead and Coordination with internal teams of mechanical, Instrumentation and
Automations as per functional requirements.
Engineering
support for Equipment Qualification activities DQ, FAT, recipient of equipment,
SAT, Commissioning, IQ, OQ, PQ-qualification of equipment as per the
Qualification protocols and Technical Support to user for various deliverables.
Responsible
for preparation of various regulatory inspections, audits and need based active
participation during audits.
Provides
process engineering support for site-to-site parenteral product transfers by
interfacing with cross functional departments across sites.
Conducts
equipment and process related technical investigations and makes
recommendations on corrective Prepares, reviews, and provides input on user
requirements specification (URS) documents and P&IDs
Will
lead activities to implement novel technologies for process improvements to
increase yield and reduce process variability
Ensure
the compliance to cGMP/cGLP, organizational procedures and practices.
Involve
in manufacturing, Validations / engineering related CAPAs and monitor the
effectiveness of CAPAs
Seek
training from technology vendors and train the end users
Pfizer
is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
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