CyberCoders Validation Specialist - GMPs/FDA for Biotech Industry Leader! in Monrovia, California

Validation Specialist - GMPs/FDA for Biotech Industry Leader! Validation Specialist - GMPs/FDA for Biotech Industry Leader! - Skills Required - Validation elements in Pharma/Biotech, cGMP regulated environment, Technical Writing, Validation element principles and procedures, Planning/scheduling & leading validation projects, Train/mentor and lead less experienced staff, Assist with regulatory agency inspections, Draft and implement Global validation procedures, Present validation strategy & protocols, Write & execute protocols and SOP

If you are a Validation Specialist with experience writing and executing protocols for the Biotech or Pharmaceuticals industry, please read on!

Are you ready to work for a company dedicated to saving the lives of children?! We are a leader in the Life Sciences industry focused on serving children who are born into the NICU. Our nutritional product line is provided to critically ill, premature infants who need immediate assistance once born. We are a company committed to pushing the envelope forward and have built an established team of scientists and engineers who are also committed to our mission. Many of our employees share an experience in their own lives that relates to our work and drives their passion to be part of our team. Our engineering team is critical to our business and we are currently hiring a Sr. Business Systems Analyst who will help with the implementation of our new ERP system. If you are ready to join a company that is making an impact and saving lives today, we are the company for you!

Top Reasons to Work with Us

  1. Saving the lives of children and newborn babies!

  2. Work in a ground breaking industry with top talent.

  3. Join a fun and dynamic work culture that provides opportunities to advance!

What You Will Be Doing

Our Validation Specialist will be responsible for the following;

  • Responsible for planning, scheduling, and leading validation assignments.

  • Demonstrate competent and effective planning, coordination, and organizational skills.

  • Review and asses change control requests with potential impact to validated state of validation elements.

  • Provides training, mentoring and leadership to less experienced staff.

  • Lead and interface with cross-functional team members ( Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation element.

  • Determine validation strategy and system validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and validation.

  • Emphasis is on ensuring accuracy and integrity on validation documentation meets regulatory guidelines and industry standards.

  • Apply thorough understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures and project management

  • Validation documentation includes but not limited to Requirements, IQ/OQ, Validation Analysis, Validation Plan, Validation Report, Validation Protocol, Risk - -

Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements (CFR Part 820) Assessment, SOPs, Traceability Matrix etc.

  • Identify gaps related to validation requirements and Global Validation procedures. Drive and close compliance gaps as they are identified.

  • Perform update to validation assessments and validation plans, as needed.

  • Assist in the investigation and closure of non-conformances/events, corrective actions and preventative actions.

  • Participate in internal or external assessments or audits, as needed.

  • Support process with timely closure of observations/audit items.

  • Assist with regulatory agency inspections.

  • Present validation strategy and protocols in regulatory inspections.

  • Lead and participate in the drafting and implementation of Global Validation procedures including initiatives for harmonization and streamlining efforts if required.

What You Need for this Position

  • Strong leadership experience in pharmaceutical/biotech validation elements

  • Experience in writing and executing of protocols and standard operating procedures

  • Strong comprehension of the operating principles in a cGMP regulated environment

  • Experience with Technical Writing

  • Extensive cross-functional team experience

  • Experience training, mentoring and leading junior staff members

  • Solid technical understanding of the validation element principles and procedures

  • Experience scheduling a series of project technical and project management overviews independently

  • Hands-on Manufacturing, Engineering or Technical Service experience is a plus!

  • Experience with Manufacturing systems, Lab Information systems or ERP systems are a plus!

  • Strong experience and proficiency in problem analysis and resolution

  • Microsoft Office including MS Word, Excel, Power Point, Visio and Project

  • Successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.

  • BA or BS degree preferably in the engineering or science field

What's In It for You

  • Great work environment

  • Flexible hours

  • True work/life balance

  • Excellent company paid for medical, dental and vision plans (Individual and family)

  • 20 days of PTO

  • Bonuses and stock options

  • 401K matching plan

  • Fun and exciting company events including poker nights, family picnics and more

  • Rapidly growing company creating professional development opportunities

  • Company that values continued education in cutting-edge technologies

So, if you are a Business Systems Analyst with experience implementing an ERP system for the Biotech or Pharmaceuticals industry, please apply today! You don't want to miss this opportunity!

Applicants must be authorized to work in the U.S.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Validation Specialist - GMPs/FDA for Biotech Industry Leader! CA-Monrovia MR-1470153