23 days old

Process Engineer

Kelly Services
Warren, NJ 07059
**Sr. Process Engineer**

**Duration = One year from start date**

**Pay $50-64 per hour depending on experience**

Typical Daily Work Hours = Mon-Fri, 40 Hrs/Wk, 9am to 6pm (some flexibility in daily start/end times)

Weekend & OT work = Very rare and unexpected

100% onsite work. (During COVID restrictions, worker will be working remotely.) Do not submit candidates that ONLY want to work remotely, even after COVID.

**WORK LOCATION: This position can be in Warren NJ or Seattle WA.**

**Job Purpose / Position Summary**

We are looking for a Process Engineer III/Sr. Process Engineer to join the Single Use Systems (SUS)/Raw Material (RM) Team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The successful candidate will collaborate with the GMSAT teams in Seattle and New Jersey locations in the US and support efforts related to SUS and RM. The Process Engineer III/Sr. Process Engineer will be responsible for leading cross-departmental teams, planning/executing risk assessments, building strategy for comparability exercises to enable change implementation, and deviation management.

This role is responsible for creating supporting/leading vendor change notifications, supporting dual sourcing strategies, proactive process monitoring using statistics, master plans, and leading investigations. This role will also be responsible for supporting and developing designs and implementation of SUS and RM best practices and new designs.

**Responsibilities include, but are not limited to, the following:**

?? Collaborate with process engineers and analytical scientists by applying in-depth SUS knowledge to support CAR-T manufacturing process teams.

?? Lead execution of process risk assessments, development of criteria justifications, and development of RM master plans.

?? Support regulatory filings summarizing the strategy and results from comparability exercises.

?? Develop, understand, and manage tools and templates that can be used to quantify potential impact of changes on process performance and product quality.

?? Lead efforts focusing on alignment and harmonization of comparability strategies across multiple sites.

?? Leverage and maintain strong relationships across multiple sites and vendors.

?? Coach/support junior staff on the team on complex technical issues

?? Up to 25% travel may be required domestically (primary) and internationally (potentially)

**Skills/Knowledge Required:**

B.S. with 7+ years, M.S./Ph.D. With 5+ years with relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent.

***Experience in managing SUS projects -- Single Use Systems ****

Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast paced matrix environment.

Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment.

Experience working in a GMP environment, familiar with ICH guidelines, and control strategy development.

Experience in development and/or characterization of vaccines, biologics and/or cell therapy manufacturing processes.

Excellent problem-solving skills

Proficiency utilizing MS Office products and statistical software (R, JMP, Minitab)

Able to creatively manage time and elevate relevant issues to project lead and line management

Strong scientific and technical writing

Detail oriented with excellent verbal and written communication skills

**Additional Skills:**

***Single Use (SU) component experience is strongly preferred.***

Flexibility to work within manufacturing schedules.

Familiarity with literature on cell therapy. Experience with cellular therapies is preferred.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-08-31 Expires: 2020-10-01

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Process Engineer

Kelly Services
Warren, NJ 07059

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