- Communication Skills
- Computer Literacy
- Process Engineering
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
Essential Duties and Responsibilities include the following:
Responsible for leading the tech transfer of client processes and executing engineering functions including design and document controls.
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 facility.
Develop new manufacturing and aseptic filling processes to meet client requirements.
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 Document Controls.
Specify and procure new process specific equipment.
Work with vendors to manufacture new process equipment as necessary.
Maintain contact and good working relationships with clients.
Educational Qualification - B.E. Chemical
Experience - 5 to 7 years in similar kind of industry.
Meticulous and highly organized.
Excellent communication skills.
Desired - Aseptic technique, familiarity with clean room personnel flows.
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 process design.
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.