Job Description - Senior Process Engineer (1003163)
Senior Process Engineer - 1003163
Albany Molecular Research Inc. provides global contract research
and manufacturing services to the pharmaceutical and biotechnology
Essential Duties and Responsibilities include the following:
Responsible for leading the tech transfer of client processes
and executing engineering functions including design and document
Identify and specify process specific equipment needed for
client tech transfer. Author instructions for the operation of
equipment and for detailing process flows in clean room
Develop new manufacturing and aseptic filling processes to meet
Ability to troubleshoot, amend and accommodate the process of
aseptic formulation and fill of drug product such that it
harmonizes with HCM Manufacturing Facility while protecting the
integrity of client technology / product.
Develop batch records and write reports.
Perform aseptic processing operations including equipment
preparation and sterilization, aseptic assembly, bulk substance
formulation and sterile filtration, to support manufacturing.
Execute Engineering functions for all quality system elements,
including CAPA’s, DR’s, Change Controls, Design Controls and
Specify and procure new process specific equipment.
Work with vendors to manufacture new process equipment as
Maintain contact and good working relationships with
Educational Qualification - B.E. Chemical
Experience - 5 to 7 years in similar kind of industry.
Meticulous and highly organized.
Desired - Aseptic technique, familiarity with clean room
Desired - Knowledge of process flows – ie. Bio disposables
strategies, filtration, mixing strategies, fluid transfer to and
from various vessels/bio bags.
Desired - Working knowledge of process engineering processing
aids such as sanitary connections, valves and pharmaceutical
Experience with SIP a plus.
Computer literate with good working knowledge of spreadsheet
software (Visio or equivalent drawing program a plus).
Ability to work with minimal supervision and interact well with
clientele as well as interdepartmentally.