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Engineer Vaccine Manufacturing Support, Cambridge, MA

Kelly Services


Location:
Cambridge, MA
Date:
04/19/2018
2018-04-192018-05-19
Job Code:
US41ALJF_BH1435221
Categories:
  • Engineering
Kelly Services
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Job Details

Job Title Engineer Vaccine Manufacturing Support, Cambridge, MA

Jobid US41ALJF_BH1435221

Location: Cambridge, MA, 02238, USA

Description **Engineer Vaccine Manufacturing Support, Cambridge, MA**

**12 Month W2 Contract via Kelly Services**


**OBJECTIVES:**


+ Supporting implementation of vaccine manufacturing and quality systems in collaboration with quality, supply chain and information technology staff. These systems include the Quality Management System and systems required for material control and supply planning.
+ Providing technical support for raw materials and components (RMC) management. Includes writing or contributing to technical assessments in support of RMC deviation management, change control or regulatory submissions.
+ Providing life cycle support and continuous improvement of Takeda’s vaccine manufacturing and quality systems. Identifying and implementing continuous improvement opportunities in vaccine operation’s use and management of RMC.
**ACCOUNTABILITIES:**


+ Partners with quality, supply chain, procurement, information technology, operations and product development groups to execute plans for manufacturing and quality system implementation.
+ Participates in cross-functional team with membership from procurement, quality, operations, supply chain management and development groups 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.
+ Responsible for writing technical assessments to support deviations, change control or certifications. Supports relevant regulatory submission sections for new processes, and/or changes to existing processes for various geographies.
+ Identifies and implements system improvements in vaccine operations to improve process performance, manufacturing efficiency and/or operations quality performance. Monitors metrics to assess performance of manufacturing and quality systems and to identify opportunities for improvement.
+ Supports execution of project plans for 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.
+ Supports risk assessment for raw material and component usage for all Takeda vaccines. Helps to identify risks and develops and implement plans to mitigate key risks. Monitors performance of critical raw materials and components and to identify opportunities for improvement.
**EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:**


+ B.S. in Engineering, Technology or Science field with at least 5 years of experience in bio- pharmaceutical manufacturing. A degree in biochemical engineering/ biotechnology or related discipline is highly preferred. 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. biological drug substance production or formulation, filling, and finishing of parenteral products).
+ Possess demonstrated leadership abilities along with technical writing, problem-solving and project planning skills.
+ Understanding and working knowledge of ERP systems (ie. SAP), preferred but not necessary.
+ The candidate must be self-motivated, able to meet project deadlines and budgets. Teamwork and collaboration skills are integral to the position.
+ 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.
**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 inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional 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 2017 was $5.4 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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