Job: Manufacturing Associate II - Nigths, Temp

Jobing Description

Manufacturing Associate II - Nigths, Temp

Department: Manufacturing
Location: Smithfield RI
Job Code: 374


Description

Department: Manufacturing

Position: Manufacturing Associate II (Temporary), Nights

Position Overview:

The Manufacturing Associate II is responsible for the execution of manufacturing operations in accordance with batch instructions and procedures. The Manufacturing Associate II is expected to have experience in operating manufacturing equipment in clinical and/or commercial cGMP drug substance manufacturing. Specific responsibilities are provided below.

Responsibilities:

* Perform and document operations in accordance with cGMPs, site quality systems and applicable company policies.
* Perform CIP (clean in place) and SIP (steam in place) of equipment as needed and have experience working with OIT s (operator interface terminals) and PCS s (plant control systems).
* Must have a technical understanding of operations carried out within area of responsibility such as:perform solution transfers, pH adjustments, filter integrity testing, filtration of product and solutions, cell culture, product harvest, centrifugation, ultra filtration / diafiltration, column packing, ultra filtration membrane installation, chromatography and bulk drug fill.
* Assist with deviations and corrective and preventative actions.
* Execute IQ, OQ and PQ (installation, operational and performance qualifications) of equipment as needed.
* Assist with special projects as required with minimal instruction.
* Provide on-the-job training and technical direction to assist in the development and qualification of junior associates and technicians.
* Effective interpersonal skills are required, as is the ability to communicate well, both verbally and in writing.
* Must be flexible and able to perform a variety of tasks effectively.
* Must have a technical understanding of operations carried out within area of responsibility.
* Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
* The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives and policies in a professional and responsible manner.

Education and experience:

* Requires a Bachelors degree in a scientific discipline or equivalent.
* Minimum of 3-5 years of experience in a cGMP biological manufacturing environment