Innova Solutions has a client that is immediately hiring for a Engineer Senior.
Position type: Full-time - Contract
Duration: 12 Months
Location: Thousand Oaks, CA
As a Engineer Senior, you will:
Description
Onsite at ATO - 3 days onsite
Looking for someone who can work independently to co-lead a product.
Technical Skills: Drug product fill finish processing, Holistic DP process knowledge.
Technical transfer, drug product manufacturing, regulatory filings.
Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance, while also leading the charge in innovative process improvement strategies.
- Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in formulation, filtration, filling (vials/syringes/devices) and lyophilization of parenteral products.
- Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites.
- Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
- Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
- Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.
- Authors and reviews guideline documents, technical protocols, reports, product impact assessments and regulatory submissions
- Identifies and implements operational opportunities for current and new sterile operations.
Preferred Qualifications
- Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
- 10+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
- Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations
- Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specifically lyophilisation would be an advantage.
- Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets:
Technical transfer, drug product manufacturing, regulatory filings
Day to Day Responsibilities:
- Create and update manufacturing process documents, work with cross functional teams on product specific investigations, complete laboratory investigations and perform routine testing, monitor process data, imitate and lead meetings related to product initiatives
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 -
Phone:
PAY RANGE AND BENEFITS:
Pay Range : $45 - $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, )
- One of the Largest IT Staffing Firms in the US - Ranked by Staffing Industry Analysts (SIA, 2024)
- One of the Largest Staffing Firms in the US - Ranked 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 :
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 or . 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.
American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.