Quality Engineer Support

Posted 4 Hours Ago
Be an Early Applicant
Overland Park, KS
Mid level
Healthtech • Consulting • Pharmaceutical
The Role
The Quality Engineer Support will oversee Quality Assurance for commissioning, qualification, and validation activities in major projects, ensuring compliance with regulatory and quality requirements. Responsibilities include reviewing documentation, escalating critical issues, providing technical consultation, and adhering to cGMP standards.
Summary Generated by Built In

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job Responsibilities

  • Provide Quality Assurance oversight for the execution, commissioning, qualification, and validation activities for major projects.
  • This may include, but is not limited to; Factory Acceptance Testing, construction oversight, execution of onsite commissioning and qualification activities, support for process validation, etc.
  • Ensure execution of capital projects consider USDA and EMA regulatory and quality requirements.
  • Review relevant documentation including user requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, validation plans / protocols, etc.
  • Escalate protocol departures of critical nature and ensure issues are addressed and remediated accordingly
  • Provide technical consultation and interpretation local procedures, corporate standards and regulatory expectations.
  • Demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and client policies and procedures.
  • Exemplify “Safety First and Quality Always” mind-set.

Requirements

  • Bachelor's of Science degree in Engineering or related fields
  • 3+ years supporting cGMP manufacturing? Additional Skills Preferences
  • Prior experience in C&Q, CQV and/or CSV
  • Proficient with computer systems including Microsoft office and electronic document management systems (Veeva)
  • Ability to organize and prioritize multiple tasks and to problem solve effectively
  • Ability to work under time pressure and exert good judgement in special situations
  • Strong communication and interpersonal skills
  • Excellent technical writing skills.
  • Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.

Up to 1 year contract opportunity; onsite in Kansas.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

The Company
Bozeman, MT
2,059 Employees
On-site Workplace
Year Founded: 2001

What We Do

ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies.

With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science

Similar Jobs

ServiceNow Logo ServiceNow

Advisory Solution Consultant, Service Ops

Artificial Intelligence • Cloud • HR Tech • Information Technology • Productivity • Software • Automation
Hybrid
Kansas City, KS, USA
26000 Employees

Superhuman Logo Superhuman

Senior Engineering Manager

Consumer Web • Enterprise Web • Mobile • Productivity • Software
Easy Apply
Remote
13 Locations
116 Employees

Leaf Home Logo Leaf Home

Leaf Home Water Solutions - LHWS Sales Rep - Wichita, KS 67202

Events • Other • Professional Services • Real Estate • Retail • Design • Manufacturing
Wichita, KS, USA
4058 Employees
250K Annually

Cox Enterprises Logo Cox Enterprises

Cloud Channel Sales Consultant II (RapidScale)

Automotive • Cloud • Greentech • Information Technology • Other • Software • Cybersecurity
Hybrid
Wichita, KS, USA
50000 Employees
85K-150K Annually

Similar Companies Hiring

Zealthy Thumbnail
Telehealth • Social Impact • Pharmaceutical • Healthtech
New York City, NY
13 Employees
Energy CX Thumbnail
Utilities • Professional Services • Greentech • Financial Services • Energy • Consulting • Business Intelligence
Chicago, IL
55 Employees
Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
46000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account