Validation Engineering

ALK is a forward-thinking allergy company with a long tradition for allergy innovation. We are making a bold move into digital to transform the way consumers, patients, and healthcare professionals address allergies. 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 2,200 employees and 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 US Offices in Round Rock, TX, Bedminster, NJ, Port

ALK has an opening for a full-time Validation Specialist , located in our Oklahoma City, OK facility.

This position will interface with levels of the organization on a daily basis observing the site's compliance to current Good Manufacturing Practices (cGMPs). 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.
• 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.
• 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.
• 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

• Must be able to read, write and speak English
• Bachelor's Degree in Engineering or Science and minimum 1 year relevant experience performing validations in aseptic manufacturing

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 scientific writing and terminology

ALK is an Equal Employment Opportunity / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Job Type: Full-time

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