Job Listing Description

THIS JOB IS NO LONGER AVAILABLE. THIS IS ARCHIVAL INFORMATION.
Validation Engineer (Pharmaceutical/Serialization)

Description:
Niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile ophthalmic solutions, ointments and jellies. The company markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies. Candidates will be required to show proof they can legally work in the US. This job is located near Amityville, NY.

Job Description
In order to comply with the FDA Drug Quality and Security Act we are seeking a qualified candidate for a 6-month contract assignment to assist in the Installation, Operational, and Packaging Performance Qualification of a coordinated bar-code system ('serialization'). The bar-code will permit 'track and trace' information regarding the manufacturing and distribution of the product. This system will operate on three packaging lines liquid fill, tube fill, and hand packing.
The validation specialist will write procedures and test scripts to operate and maintain the new equipment and to challenge system for compliance with FDA requirements and system lifecycle requirements. The validation specialist will perform Factory Acceptance Testing as well as assist in Site Acceptance Testing, IQ, OQ and PQ.

Candidate Qualifications
-The primary responsibility is to execute test scripts (protocols) to ensure the proper operations of the bar-code system and packaging line upgrades.
-Also establishing the process and equipment acceptance criteria, and developing and performing qualifications studies to document evidence which provides a high degree of assurance that equipment and processes will consistently produce a product meeting its predetermined specifications and quality attributes.

Essential Functions
-Schedule and plan equipment and process qualification workload to meet approved schedules.
-Technical writing procedures and test scripts.
-Actively participate in defining and approving User Requirement Specification (URS), Functional Specification (FS) and Design Specification (DS).
-Design and attend F.A.T. testing at vendor facility, as required.
-Write, execute, and review complex protocols including IQ, OQ and PQ.

Qualifications
-To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
-The requirements listed are representative of the knowledge, skill and/or ability required.
-Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience
-Bachelors of Science degree in Engineering or relevant science.
-Three years’ experience in the pharmaceutical industry, or equivalent experience.
-Demonstrate experience and knowledge of qualifying changes to validated systems/processes/and equipment.
-Experience of validating a serialization or track & trace project is highly advantageous
-Understanding of packaging processes, warehouse and distribution streams
-Excellent Technical Writing and Communication skills

Job Prerequisites
-Ability to meet attendance standards. All full time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
-Previous experience in the pharmaceutical industry with a manufacturing background.
-Advanced knowledge of cGMP’s and regulatory requirements as they relate to IQ/OQ/PQ
-Knowledge of software validation is highly advantageous
-Knowledge of vision system technology is a plus.
-Knowledge of bar code technology (e.g. GS1-128 Linear) is a plus.
 
Job Location: Amityville, NY
Rate: $60/hr
Per Diem: Yes
Overtime: Yes
Duration: 6 mos
Start Date: ASAP
Input Date: 11/14/2020
Firm Name: STERLING ENGINEERING
Attention: Gina McDermott
Address: 2 WESTBROOK CORP CTR STE 300
City, State: WESTCHESTER, IL 60154-5721
Phone: 630/993-3433
800 Phone: 866/478-3754
Fax Phone: 630/516-1192
Website: www.sterling-engineering.com

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