Validations Specialist

ALK-Abello, Inc•Port Washington, NY

10d•Onsite

About The Position

ALK is a forward-thinking allergy company with a long tradition of allergy innovation. ALK is devoted to improving quality of life for people with allergies by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) – a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction. Since 1923, we have been working to improve the quality of life for allergy patients by developing products that target the cause of allergy. With over 2,300 employees, and with subsidiaries, production facilities and distributors worldwide, we are in a unique position to further the advancement of allergy treatments. The company is publicly traded on NASDAQ OMX Copenhagen (OMX: ALKB) with global headquarters in Horsholm, Denmark and offices North America. We are currently looking for a Validations Specialist to join our team in our Port Washington, NY facility. This is an entry to mid-level Validation position. This position will interface with levels of the organization on a daily basis observing the site’s compliance to current Good Manufacturing Practices (cGMPs). The successful candidate will design, execute and close validation protocols and must be capable of working independently and within a group environment.

Requirements

Bachelor’s degree in engineering or science preferred.
Minimum 3 years relevant experience performing validations in pharmaceutical/ manufacturing environment.
Prior experience with cGMP activity required.
The ideal candidate must be willing to be held accountable and must work well with others in order to ensure that all objectives are met on a regular basis
Excellent written and verbal communication skills.
Must be proficient in Microsoft Office applications, particularly Word and Excel.
Excellent scheduling and time management skills with daily operations and special projects.
Knowledge of cGMP, cGDP and cGLP.
Knowledge of scientific writing and terminology.

Responsibilities

Establish validation policies and procedures ensuring compliance with global regulations and corporate standards.
Work directly and indirectly with site management to schedule and execute validation activities to support the business plan.
Participate in the Validation project teams.
Proactively identify and resolve validation issues.
Author, execute and follow up closure documentation for Installation (IQ) Operational (OQ) and Performance (PQ) Qualifications.
Be knowledgeable performing review, authoring and revisions of Standard Operating Procedures and related manufacturing process documentation.
Perform duties related to the documentation and follow up to Corrective Preventative Action plans and Change Control.
Provide validation support for the introduction of new equipment or modification of equipment.
Input equipment and data into calibration software.
Preparation of summary reports, deficiency/discrepancy reports, gap analysis, risk analysis, failure mode & effect analysis, traceability matrices.
Knowledgeable in validation of pharmaceutical equipment including autoclaves, depyrogenation ovens, coolers, and other manufacturing equipment.
Assist with the development of such documents as: Validation Master Plans, Computerized System Validation, System Design Specifications, Users Requirements Specifications, Detailed Design Specifications.
Continuous mental and/or visual attention to manufacturing functions.