Validation Engineer

Profile

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: https://www.astellasgenetherapies.com/

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx ® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

Be

BOLD (Find a Way)

Care Deeply

for our patients, each other and our work

#GSD

(Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

As part of the Astellas Gene Therapy Manufacturing Sciences and Technology (MSAT) team reporting to the Manager, Validation the

Validation

Engineer is

responsible for

implementation and execution of the validation activities for facilities, utilities, equipment, analytical equipment, cleaning validation and process performance qualification at the AGT production facility in South San Francisco, CA. Validation Engineers will be SMEs in multiple validation disciplines, who will be responsible for leading validation strategy, managing and executing validation projects

, and

managing contract support, while ensuring compliance and implementation of data integrity.

We are seeking highly motivated Validation Engineers with a desire to grow and develop their validation knowledge base.

Primary Responsibilities

Manage contract C&Q support staff in order to qualify facility, equipment, utilities and QC equipment for GMP readiness.

Review and approve validation documentation for facilities, equipment, utilities and QC equipment for GMP readiness including specification documentation eg: URS/FRS/DS/IQ/OQ/DQ/TM/PQ.

Define validation strategies as it relates to PPQ and prerequisites and drive validation project implementation to ensure deliverables are brought online within timelines and with a high degree of quality.

Draft validation program documents, VMPs and VSLs in alignment with defined AGT validation program.

Review and implement validation procedures that provide instruction for the execution and maintenance of the validation program including CSV, QC method, facility, utility, equipment and process validation.

Design specific validation protocols, leads the execution of the validation studies including resolving technical issues, evaluating results, and generating reports.

Work closely with stakeholders including Quality Operations, equipment providers and capital project teams in support of the development of and subsequent qualifications and validations of facility and technical systems.

Partner with Engineering and Facilities to review and support facility and equipment commissioning.

Assess and resolve validation impact of change controls, deviations and discrepancies encountered during validation execution through science-based quality risk assessments.

Compile, analyze and manage validation data and records and ensure approval and archival within the AGT quality system.

Requirements

Must Have/Required

Industry experience with typically 8 years relevant experience, or BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study with typically 4 years relevant experience or Master's degree with a typically 2 years relevant experience.

Strong knowledge of risk-based approach to commissioning, qualification and validation activities in a biotech manufacturing environment.

Strong problem-solving, decision-making skills, interpersonal skills and ability to work in a team.

Strong understanding of FDA, EMA, local regulations and guidelines, Good Engineering Practices, ICH guidelines, Data Integrity and industry best practices.

Validation experience using risk-based approaches, e.g., failure mode and effects analysis, hazard analysis and critical control points, etc.

Experience with investigations into validation discrepancies and evaluating validation impact potential, root cause, and corrective actions.

Excellent technical writing, verbal communication and time management skills.

Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines.

Some travel (up to 10%) will likely be required.

Models our Core Values: Be Bold, Care Deeply, #GetStuffDone

-- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

Experience with process validations, specifically developing and executing process performance qualifications (PPQ).

Experience with validations performed on analytical lab equipment including designing and executing testing relating to Data Integrity requirements.

Ability to deal with ambiguity, creative and pragmatic approach to problem solving.

Direct experience in r

egulatory compliance with respect to validation.

Exposure to regulatory authority inspections and inspection readiness.

Benefits:

Medical, Dental and Vision Insurance

Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

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

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Type

Full-time

Location

CA, South San Francisco

Category

MSAT

Company info

Astellas Us, LLC
Website : https://www.astellas.com/us/