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

OBJECTIVES:

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.

ACCOUNTABILITIES:

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.

Why Kelly?

  • 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*

Apply Today!

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