Manufacturing Technical Operations Contractor

Innova Solutions is immediately hiring a Manufacturing Technical Operations Contractor

Position type: Full-time

Duration: 12 months Contract

Location: West Point, PA

As a Manufacturing Technical Operations Contractor, you will:

Summary: The Specialist is responsible for technical support and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture. In this role, the contracted person will work as an individual contributor, may act as a team or project lead, and lead the work of others as required, as well as contribute to the performance and results of a department. Additionally, this individual will provide technical guidance and anticipate and interpret needs to identify and implement solutions.

Responsibilities:

• Establish and manage project schedules and timelines, Determine project resource requirements, and works with stakeholders to gain the support needed from subject matter experts. 
• Stakeholders may include Operations, Quality, Regulatory, Analytical, and Process Development functions.
• Responsible for stakeholder engagement, communication, and risk escalation.
• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
• Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Consistent application of standardized work, engineering, and process tools (i.e. TrackWise, IPI, MS Project, Excel).
• Provide technical support to manufacturing for problems and issues.
• Work as a team member on complete manufacturing investigations, process improvement, and/or validation projects.

Qualifications:
Education Minimum Requirement

• Bachelor's Degree in Engineering or Science. 

Required Experience and Skills:

• Minimum of two (2) years of work experience in the biological/ pharmaceutical/chemical manufacturing industry. 
• Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role. 
• Minimum of six (6) months’ work experience with cGMPs, Change Control, CFR, and other appropriate regulations to vaccine manufacturing. 
• Experience w/Microsoft Office suite, and process tools (i.e. TrackWise, IPI, MS Project, Excel). 

Preferred Experience and Skills:

• Strong understanding of Change Control and Project management, Demonstrated ability to work both independently and as a part of a team. 
• Strong technical problem-solving abilities. 
• Demonstrated effective written and verbal communication skills. 
• Strong collaboration skills. 
• Familiarity or experience with aseptic Vaccine Manufacturing Operations or Equipment. 
• Experience with the introduction of process changes to a licensed process.

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!

Charan Chiraboina

charan.chiraboina@innovasolutions.com

Team Lead

PAY RANGE AND BENEFITS:

Pay Range*: $40.00/hr to $43.00/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:

· One of the 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.