Process Engineer/Scientist I - Tech Ops

Job Description

Job Description

Process Engineer/Scientist I – Tech Ops
Full-Time
M-F, 1st Shift-
Possibly 1-2 days from home
Compensation: $38-41/hr
Must be able to supply your own laptop

Kelly Science is currently seeking a  Process Engineer/Scientist I – Tech Ops
for a long-term engagement at one of our Global clients in  Summit, NJ . If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

The role is eligible for medical benefits, paid time off including vacation (PTO), and holidays, 401K, and annual performance reviews.

RESPONSIBILITIES

• Collect and review historical data.
• Initiate Development Plan for each formula.
• Assign Development Plan Deliverables to Cross Functional team partners.
• Coordinate with Team Members on their contributions to be included in the Development Plan.
• Route Development Plan and manage Approval Process.
• Initiate and write change controls.
• Route change controls and manage approval process.
• Create, update, revise, and manage approval process for specifications (Manufacturing Work Instructions, Formula/Device specification, Product specification, Finished Good specification) as required.
• Manage any BRF revision / modification process.
• Review Pilot/Trial Batch Cards submitted by Manufacturing Site.
• Write Bulk Holding Protocols and manage approval process as required.
• Review and Approve Validation(s) Batch Cards submitted by Manufacturing Site.
• Write the Process Development Summary.
• Provide MS&T deliverables to change controls or to Authorization for Product Release (APR).
• In conjunction with project manager, ensure that partners are providing deliverables to change controls or to APR.

When all deliverables are provided, route change controls or APR for review and approval.
Provide ongoing general assistance in various miscellaneous department activities.

• Provide ongoing solutions to general challenges and issues that arise.
• Support External Manufacturing Investigations.
• Provide technical justification to support change of equipment, manufacturing processes.
• Conduct technical review of site requests.
• Participate in regular cross-functional team meetings and deliver key milestones
• Work with cross functional partners to coordinate work, to get directions and alignment.

QUALIFICATIONS

• Bachelors in Chemical Engineering, Biomedical Engineering, or similar (BS in Chemistry, Biochemistry, etc)
• 3+yrs of experience supporting technical writing, formulating/batching, and technical operations within a cGxP environment (pharma, biotech, or consumer products preferred)
• Must have experience handling site transfers/ equipment qualification/ investigations) and working on change control
• Technical Skills: Data analysis, change control, specification writing/revision, process/equipment justification.
• Project Management: Plan initiation, task delegation, cross-functional coordination, progress tracking.
• Communication: Excellent written/verbal skills, clear documentation.
• Analytical Skills: Data analysis, problem-solving.
• Additional: Manufacturing experience, GMP understanding, teamwork, attention to detail.
• What happens next

  Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more

  #P1

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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