Engineer
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring for an Engineer

Position type: Full time Contract.
Duration: 18 months
Location: Thousand Oaks, CA

As an Engineer, you will:

Job Description:
Must be local to Thousand Oaks, CA will work hybrid (typically onsite about twice per week sometimes more)
The Engineer, in Physical Methods, is responsible for engineering activities required for the development /qualification / validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging parts.
The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost.
Phases of projects include developing combination product test methods, providing key experienced support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.

Responsibilities:
Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
Provide experienced support for investigations as well as new process development required to improve manufacturing operations.
Coordinate test method development and delivery with selected contractors.
Ensure that qualification parameters are met for product assembly requirements.
Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
Generate procedures necessary to support department and new process equipment.
Provide experienced training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department (i.e. production operator, mechanics, process engineers).
Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
Generate/author and be responsible for the Test Method documents.
Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design
Perform other duties as required by the Group Manager
Align with the requirements, responsibilities, and authority as required
Maintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work
Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects
Networks with manufacturing, quality and regulatory organizations both internal and external to Client
Drives the multi-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
Excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership
Collaborates with other functional leaders to ensure project success, momentum and commitment
Proactively identifies issues and/or risks and develops mitigation options to resolve or increase efficiently
Integrates partner/vendor timelines with Client timelines as appropriate

Preferred Qualifications:
M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
Excellent written and verbal communication skills
Ability to work in a highly matrixed team environment
2 years of experience in the biotechnology/pharmaceutical industry
2 years of experience in equipment, method, and mechanical design
Technical writing experience
Experience with SolidWorks (or other 3D-CAD software)
Experience with combination products and regulatory requirements
Experience applying Minitab (or other statistical software packages)

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.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!

Namrata Gautam
Senior Associate Recruitment
PHONE: (+1) 314-523-1818
EMAIL: Namrata.Gautam@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay Range*: $34- $38 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 centres 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:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

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.

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