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ALK • Oklahoma City, Oklahoma, United States
Salary: $55,000 - $65,000 / year
Role: Validation Specialist (Entry to Mid-level), full-time, on-site in Oklahoma City, OK.
cGMP framework; IQ/OQ/PQ validation execution
SOP development/revision; validation master plans
Computerized System Validation concepts
Documentation: deviation/deficiency reports, risk analyses, FMEA, traceability matrices
Data/calibration input; MS Office (Word, Excel)
Establish validation policies/procedures ensuring global regulatory and corporate compliance; schedule and execute validation activities with site management.
Author, execute, and close validation documentation for installations, operations, and performance qualifications; contribute to Validation Review Board.
Identify and resolve validation issues; support new equipment introductions/modifications; manage related CAPAs and change control.
Bachelor’s degree in Engineering or Science; at least 1 year of validation experience in aseptic manufacturing
Knowledge of cGMP, cGDP, cGLP; strong written/verbal communication
Proficiency in Microsoft Office; good scheduling/time-management; ability to work independently and in teams
Experience with Validation Master Plans, Computerized System Validation, system design/user specifications
Familiarity with risk analysis (FMEA), traceability matrices, and change control processes
Experience preparing summary and deficiency reports, gap analyses
About ALK
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 Washington, NY, Post Falls, Idaho, Luther, OK, Oklahoma City, OK and Mississauga, Canada.
ALK has an opening for a full-time Validation Specialist, located in our Oklahoma City, OK facility.
Area of Responsibilities
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. The successful candidate will be capable of working independently and within a group environment.
The following is a list of specific duties, which are considered to be essential functions of this job. This list is not all-inclusive, and the employee who occupies this position is expected to assume any/all duties assigned by management, irrespective of whether such duties are specifically included in this list.
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 Review Board.
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.
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 handle multiple priorities at one time
Must be able to read, write and speak English
Must be able to see
Competences
Minimum required: Bachelor’s Degree in Engineering or Science and minimum 1 year relevant experience performing validations in aseptic manufacturing
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