Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Westborough, MA.
Purpose and Scope:
The primary purpose of the Validation Specialist position is to provide commissioning, qualification and validation support to a cGMP Cell Therapy Manufacturing plant. This position provides scientifically sound, documented evidence that our systems and processes will perform as required to standards set forth by Quality Assurance, internal clients and global regulatory bodies. The evidence provided through the CQV program will ensure a quality, complaint manufacturing and testing environment. Validation Specialist will support CQV mission that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines.
Essential Job Responsibilities:
Author technical documents such as protocols, reports, user requirements statements, deviations and risk assessments etc. Write, execute and approve validation protocols and reports following good documentation practices.
Interface with system owners, IT and facilities engineering to ensure all user and compliance requirements are tested as well as support the creation of the requirements for new equipment or products
Evaluate vendor qualification packages and create wrappers as necessary
Ensure data and record integrity through GDP
Generate, execute and review completed qualifications and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
Uses validation software, Ellab ValSuite dataloggers to perform mapping studies.
Maintain close contact with manufacturing, facilities and laboratory departments to assure effective communication on issues related to validation and the validated state of equipment and endure effective communication on validation issues.
Perform periodic review of equipment and systems.
Develop testing strategies and rationale for equipment/systems.
Assist transfer, business development and project management teams in determining and planning studies required for new products.
Write and revise SOPs and Validation plans as part of routine document lifecycle of as part of improvements.
Provide technical or investigational support in troubleshooting and resolving validated equipment or system issues. Investigate and troubleshoot problems that occur and determine solutions and recommendations for changes and/or improvements.
Supplies management with relevant compliance insights; highlights and engages continuous improvement opportunities.
Quantitative Dimensions:
This position directly supports key objectives by establishing and/or maintaining compliance for new and existing product lines. Validation plays a key role in the successful, timely launch of new products and the progression of current products through their clinical lifecycle.
Organizational Context:
Reports to the Senior Manager of Quality Systems.
This position is an individual contributor role but works as part of a team within the larger GMP Quality Assurance department at AIRM.
This position requires onsite work
Qualifications:
Required
BA/BS or equivalent with typically 1+ years relevant experience or typically 0 years with Masters degree
In lieu of a Life Sciences degree, consideration will be given to candidate with minimum of 3+ years of relevant industry experience in biotechnological and/or pharmaceutical quality assurance and/or quality engineering
Familiarity with most major elements of job description, direct experience with at least one major area
Familiarity with some of the major compliance regulations and consensus standards including 21CFR §11, §210, §211, §1271; Eudralex Volume IV (including ATMPs), ICH Q9, Q10, etc.
Excellent communication and interpersonal skills.
Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment.
Ability to exercise sound judgment, tact, diplomacy, integrity and professionalism in all interactions.
Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
Proven track record of excellent judgment, problem resolution, teamwork, some budgeting and/or excel skills, decision-making skills, and the ability to work under pressure required.
Strong proficiency in MS Word, Excel, PowerPoint, to include basic formulas, and creation / formatting of charts and data tables.
Preferred
Experience with an electronic document management system
Working knowledge of cell culture manufacturing platforms
Comfort presenting data, facilitating meetings with senior stakeholders, and maintaining minutes of key decisions and outcomes
Solid technical writing skills and ability to document work a meticulous, accurate and timely manner.
Solid written and oral communication skills and ability to work interdepartmentally with some basic supervision in an effective manner to carry out daily duties.
Experience in an environment subject to regulatory audits
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
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Category Institute for Regenerative Medicine
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans