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 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.

Education:

Minimum required: Bachelor’s Degree in Engineering or Science and minimum 1 year relevant experience performing validations in pharmaceutical/ manufacturing environment

Experience:

• 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

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.