Kelly Services Manufacturing Engineer - Vaccine Support, Cambridge, MA in Cambridge, Massachusetts
Manufacturing Engineer - Vaccine Support, Cambridge, MA
Vaccine Technology and Engineering
Six month W2 via Kelly Services
The Vaccine Manufacturing Support Engineer will be responsible for:
Providing technical support for raw materials and components (RMC) sourcing and management for the Client’s Vaccines portfolio.
Assessing and managing risk associated with RMCs and working with suppliers and third parties to implement mitigation strategies.
Writing or contributing to technical assessments in support of RMC deviation management, change control or regulatory submissions.
Supporting implementation and continuous improvement of manufacturing and quality systems in collaboration with quality, supply chain and IT.
The Vaccine Manufacturing Support Engineer is accountable to:
Create and execute strategies for ensuring robust and reliable supply and performance of critical RMCs. Focus areas may include single-use components, animal-derived raw materials, etc.
Work cross-functionally with membership from Procurement, Quality, Operations, Supply Chain Management, and Development to ensure smooth implementation supply agreements for RMCs.
Act as a Technical interface between the Client and various RMC suppliers during evaluation, selection, introduction and ongoing supply phases of implementation. Works cross-functionally to address technical supply issues as needed.
Support ongoing risk assessment for RMCs used in vaccines. Helps to identify risks and develops and implement plans to mitigate key risks. Monitors performance and identifies opportunities for improvement.
Own technical assessments to support deviations, change control or certifications related to RMCs. Complete associated documentation and track technical aspects of any associated CAPAs to completion.
Support relevant regulatory submission sections for new processes, and/or changes to existing processes for various geographies.
Support the implementation of manufacturing and quality systems for vaccines, including the business processes, operating procedures, IT solutions and rollout/training/change management required across the organization.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
B.S. in Engineering, Technology or Science field (Biotech preferred).
5 years of experience in bio- pharmaceutical manufacturing.
Specific experience in manufacturing and quality systems or in raw materials and components management is a plus.
Must demonstrate knowledge of cGMPs, with applied knowledge of bio-pharmaceutical manufacturing (e.g. drug substance or parenteral products).
Experience with audit inspections and the preparation of responses to regulatory submission questions from agencies is a plus.
Demonstrated ability to work with efficiency across multiple project teams and business functions. Teamwork and collaboration are integral to this position.
Demonstrated leadership abilities along with technical writing, problem-solving and project planning skills.
The candidate must be self-motivated, able to work independently to meet project deadlines and budgets.
TRAVEL REQUIREMENTS: 20%
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group-rate insurance options available immediately upon hire*
Why Kelly ® ?
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm