Title: Process Engineer
Location: New Brunswick NJ (remote)
Duration: 12 months
Payrate: $ 50-60/hr.
The successful candidate will provide systems, documentation and technical support for manufacturing of BMS biologic drug products at Contract Manufacturing Organizations (CMO’s) in the US.
This position will report into the Associate Director of Parenteral ExM MS&T
- Provide first line systems and documentation support to manage QE and Change Controls at CMOs in Trackwise, Infinity and other Quality and document systems
- Provide technical support to contract manufacturing organizations to enable technology transfers and commercial manufacturing. This includes review and approval of site documents such as characterization Protocols, Validation Protocols, Process Risk assessments, etc.
- Support of critical manufacturing or complaint investigations including, root cause analysis, CAPA generation, and impact assessment
- Hands-on experience with quality systems, documentation systems and ability to process change controls, deviations and CAPAs. Good knowledge of Sterile or Biologics manufacturing technology, and experience in working with CMOs with a minimum of 5 years of experience is required.
- A bachelor’s degree in relevant engineering or science discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) or requisite equivalent experience is required.
Experience / Knowledge Desired:
- Experience of working with trackwise and or infinity system to provide documentation support for change control and investigation
- Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
- Strong technical writing skills.
- Demonstrated strong oral and written communication skills, along with demonstrated project management experience.
• Ability to work within cross-functional technical teams, across multiple cultures.
As a Kelly employee, you’ll have access to premier perks, including:
- Kelly-sponsored Affordable Care Act health care coverage available to eligible employees
- Group insurance options
- Service bonus plan
- Holiday pay plan
- Weekly electronic pay options
- Online training campus that provides more than 3,000 free courses to help improve and develop skills
- Outstanding online employee community Corporate discounts
- Transportation Spending Accounts
- Offered and coordinated by Leslie & Associates. These plans are not sponsored by Kelly Services.
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, we’re here every step of the way to find your dream engineering job.
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.]]
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