engineering / validation - validation engineer (juno)

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries.

We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.

Company:

One of Our Clients

Job

Description:

Position:

Validation Engineer

Location:

Seattle, WA

Duration: 12+ Months (Extendable)

Pay Rate:

$71.00/hr on W2.

Description:

Reporting to the Vector Process Validation Lead within Global Manufacturing Science and Technology, this role will define and implement the process validation strategy and studies for BMS's lentiviral vector products.

This role will be responsible for the development of process validation master plans, process validation study design, protocols, and reports and implementation at both internal and external manufacturing sites.

The role will provide technical oversight for initial process performance qualification (PPQ) as well as throughout the product life cycle.

Candidate will interface with the Site MSAT and other cross-functional groups to ensure the process validation strategy is appropriate. The candidate will also contribute to process validation-related investigations, troubleshooting efforts, and responses to emerging requirements or questions during health authority interactions.

Candidate will participate in the development of process characterization and process control strategies as needed to ensure that the control strategies are consistent with the process validation standards and manufacturing requirements.

Required Competencies:

Knowledge, Skills, and Abilities:

• Sound scientific understanding of process validation principles
• Good understanding of the global health authority expectations around process validation
• Understanding of GMP concepts and quality systems necessary to ensure sound process validation framework
• Good understanding of equipment/system design and validation
• Excellent communication skills, both oral and written
• Experience with development of Process Validation Master Plans, Process Validation Protocols, and Process Validation Reports

Education and Experience:

• Required Bachelor's Degree in Life Sciences or Chemical Engineering
• Minimum 5 years of experience in pharma/biotech industry, min 2 years of validation experience in a GMP environment
• Preference will be given to candidates with Cell Therapy experience

Duties and responsibilities:

• Develop and implement validation policies to define robust process validation program within the cell therapy product lifecycle.
• Participate in generation and approval of PPQ enabling deliverables generated during late stage process development and characterization.
• Define process validation strategy for upcoming products and support PPQ execution in a multi-site commercial environment.
• Author CMC content for regulatory filings.
• Represent validation on contract manufacturing projects, including vendor selection, process transfer and process validation. Direct responsibility for validation activities at contract manufacturing organizations, including validation gaps assessments during CMO selection and tech transfers
• Provide oversight via review and approval, as appropriate, of site level deliverables, including Validation Master Plans, process validation protocols and risk assessments.
• Develop and implement continuous process monitoring strategies and ensure process validation status throughout commercial lifecycle
• Respond to site independent process validation troubleshooting issues, questions
• Coordinate responses to health authority questions on process validation.
• Work with process, analytical development and MSAT groups to review, approve the development of process characterization and process control strategies as needed to ensure that the control strategies are consistent with the process validation standards and manufacturing requirements.
• Author, review and approve, as needed, various validation documents including, but not limited to, protocols, PPQ plans, final reports and process validation master plans

WORKING CONDITIONS (US Only):

• The position will work in an office environment and will need to write complex documents and final reports using a computer.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.

The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Equal Employment Opportunity Statement:

Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation.

Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.

All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Awards and Accolades:

America's Most Honored Businesses (Top 10%)

Awarded by USPAAC for Fastest Growing Business in the US

12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)

Fastest 50 by NJ Biz (2020, 2019, 2020)

INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)

Top 100 by Dallas Business Journal (2020 and 2019)

Proven Supplier of the Year by Workforce Logiq (2020 and 2019)

2019 Spirit of Alliance Award by Agile1

2018 Best of the Best Platinum Award by Agile1

2018 TechServe Alliance Excellence Awards Winner

2017 Best of the Best Gold Award by Agile1(Act1 Group)

Regards,

Kenneth Solomon

Delivery Lead (Pharma and LifeSciences)

Net2Source Inc.

Global HQ Address -270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA

Office:

x 606 | Cell: | Fax: | Email:

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