Validations Specialist at ALK

About ALK

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 2,200 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 US Offices around the country.

We are currently looking for a Validations Specialist to join our team in our Plainville, CT 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). The successful candidate will design, execute and close validation protocols. The successful candidate will be capable of working independently and within a team environment

The following is a list of specific responsibilities, 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. 

Primary Responsibilities:

• Develop, implement, and communicate the Validation and Calibration strategy to the facility and organization as needed
• Establish validation policies and procedures ensuring compliance with global regulations and corporate standards
• Direct Validation and Calibration activities across multiple functional areas in facility
• Assist with GMP inspections and audits from regulatory authorities as needed
• Work collaboratively with internal and external suppliers and with regulatory agencies to resolve Validation and Calibration issues and maintain cGMP compliance
• Support activities for facility including authoring, reviewing equipment calibration protocols, validation reports, and respective data
• Participate on Validation/Calibration Project Teams
• Proactively identify and resolve validation and calibration issues
• Provide validation support for the introduction of new equipment or modification of equipment
• 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 (SOP) and related manufacturing processes documentation
• Prepare/Write change control reports and deviation reports as necessary
• Perform duties related to the documentation and follow-up to Corrective Preventative Action (CAPA) plans and Change Control
• Track equipment and data in 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

Skills and Experience:

• Bachelor’s degree in Engineering or relevant scientific dicipline preferred
• 3-5 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
• Experience coordinating vendors and contractors
• 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 cGXP
• Knowledge of scientific writing and terminology

Physical/Mental:

• 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

Business Environment:

• Effective judgment in a fast-paced, results-orientated environment

Approximate annual salary range for this role: $70,000 to $90,000. This salary range is an estimate in good faith for the position. Final compensation can vary based on the candidate's relevant experience, skills, and knowledge.

This position is not eligible for Visa Sponsorship.

Why ALK?

At ALK, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.

ALK offers:

• Excellent benefits including medical, dental, and vision
• Life and Disability insurance covered at 100%
• 401(k) plan with generous employer contribution
• 13 company-paid holidays per year

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.