Innova Solutions has a client that is immediately hiring Specialist Manufacturing.

Position type: Full-time- Contract
Duration: 12 Months
Location: Thousand Oaks, CA 91320 (ONSITE)

As Specialist Manufacturing, you will:

Job Description:
The NPI Lead is expected to have ownership over the Technology Transfer Project Planning. A high degree of interactions and collaboration is required across these groups, and the NPI Lead needs to be able to understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines.
Candidates will need to demonstrate knowledge of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. The NPI Lead will be responsible for leading cross-functional projects to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of the immediate team.

The NPI Lead will be primarily responsible for:
* Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
* Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
* Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
* Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
* Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.

Additional Responsibilities include:
* Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
* Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
* Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
* Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
* Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
* Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
* Representing the team at plant-wide and network-wide forums, as needed.

Basic Qualifications:
* Master's degree in Engineering, Biology, Chemistry or Life Science Field
* Bachelor's degree in Engineering, Biology, Chemistry or Life Science Field & 2 years of directly-related GMP manufacturing experience OR
* Associate's degree & 4 years of directly-related GMP manufacturing experience OR
* High school diploma / GED & 8 years of directly-related GMP manufacturing experience.

Preferred Qualifications:
* Project Management experience
* Direct and/or indirect people management / leadership experience
* Understanding of Drug Product Formulation and Vial/Syringe Filling operations
* Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
* Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff

* Direct experience with regulated environments (e.g., cGMP etc.)

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Thank you!
Lailun Sheikh
Phone: 412-763-1477
Lailun.Sheikh@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay Range*: $40.00-$47.00 per hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• Named One of America's Best Employers for New Grads by Forbes (2024

• Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)

• One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)

• One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)

• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)

• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)

• AWS Advanced Tier Services Partner with 100+ certifications

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. * 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.PDN-9eef8fe4-331d-4efe-96ac-19dc61548385