Engineer Senior

Innova Solutions has a client that is immediately hiring for a Engineer Senior.

Position type : Full-time - Contract

Duration : 18 Months

Location : Remote

As a Engineer Senior, you will :

Description

The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary container, and secondary packaging components, as required.

This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.

Responsibilities

• Assure transfer of new combination product test methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.
• Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
• Apply core engineering principles to develop physical test methods for medical device and combination product systems.
• Perform data analysis to support method development, qualification, validation, and transfer ? Provide expert support in the design or redesign of tools and / or equipment required for manufacturing processes.
• Provide expert support for investigations as well as new processes development required to improve manufacturing operations.

Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).

• Coordinate gauge and equipment development and delivery with selected contractors.
• Ensure that qualification parameters are met for product assembly and performance 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 product equipment.
• Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to 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). Supervise work of support staff during development and manufacture of system.
• Excellent communication (written and verbal) and organizational skills ? Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables ?

Networks with manufacturing, quality and regulatory organizations both internal and external to Client ? Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.

Proactively identifies issues and / or risks and develops mitigation options to resolve or escalate efficiently ? Integrates partner / vendor timelines with Client’s timelines as appropriate

Basic Qualifications :

Doctorate Degree OR Master's Degree and 3 years of Engineering experience OR Bachelor's Degree and 5 years of Engineering experience OR Associate's degree and 10 years of Engineering experience OR High school diploma / GED and 12 years of Engineering experience.

Preferred Qualifications :

• S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering
• Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
• Experience with managing technical teams, including setting priorities and leveling resources ? Technical writing experience
• Spanish language skills preferred
• Experienced with SolidWorks (or other 3D-CAD software)
• Familiar with equipment and software IOQ
• Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs
• Experience with change controls, deviations, CAPA
• Experience with combination products and device regulatory requirements
• Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
• Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
• Experience with machine controls (PLC, HMI) and vision systems

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!

Pradip Joshi

Email - [email protected]

Phone : 213-401-2633

PAY RANGE AND BENEFITS :

Pay Range* : $48- $50 / Hr

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.