What are the responsibilities and job description for the Validation Specialist position at CSL Seqirus?
Job Details
Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.
The Validation Specialist will be reporting to the Validation Manager. You will work onsite at our CSL Seqirus in Holly Springs, NC location. Our benefits include an Onsite Caf, 1/2 mile Walking Trail, Basketball and Tennis Courts; access to Medical, Dental, Vision, Life Insurance, 401K with a 6% match and an annual bonus; and accrued PTO, wellness days and floating holidays.
Responsibilities:
- With support, plans and executes qualification and validation activities in compliance with company standards and regulatory guidelines
- Provide technical advice on qualification and validation issues to several functions (such as R&D, MS&T, Tech Transfer, etc)
- Help develop and maintain documentation (protocols, reports, etc.) for qualification and validation activities
- Support management of vendors, assessing, approving and managing compliance for approved vendors using local and global quality systems
- Help develop programs and standard operating procedures (SOPs) and provide technical support/training on validation and regulatory requirements
- Communicate cross functionally regarding needs and status of assigned activities and project deliverables
Qualifications:
- Bachelor degree in Engineering, Mathematics or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.)
- 2 years' quality systems/validation experience in pharmaceutical manufacturing/a highly regulated industry
- Knowledge of current Good Manufacturing Practices (cGMP)
- Knowledge of FDA and EMA requirements
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.
Please take the time to review our to see what?s available to you as a CSL Seqirus employee.
About CSL Seqirus
is part of. As one of the largest influenza vaccine providers in the world, CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
We want CSL Seqirus to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more .
Do work that matters at CSL Seqirus!
Watch our ?On the Front Line? video to learn more about CSL Seqirus