Validation Specialist II

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Job Summary:
Responsible for validations and equipment, facility, and system (EFS) qualifications. Ensure the annual requalification and validations described in the VMP are scheduled and performed on time. This is done by working with internal staff to ensure all barriers with regards to validations are identified and removed, as well as developing and managing relationships with lab staff through continual communication.
Mentor staff and perform basic training on validated instrumentation and processes.
Review non-routine repairs for potential revalidation. Assess new equipment for qualification. Assign open expiry for incoming chemicals, reagents, and assist with the quality assessment of incoming supplies.

Essential Duties:
Validations:

• Write, execute protocols, and document test results in accordance with current standards.
• Compile raw data and final report into completed binder.
• Coordinate efforts to ensure VMP is maintained on time.
• Review workload and coordinate strategies to utilize resources to meet on time schedule.
• Act as project owner and collaborates with and across teams to ensure timely
• completion of assigned projects.
• May travel to complete qualifications at internal or external labs.
• Collaborates with and across teams to resolve complex issues.

Quality Control:

• Control Charting as needed.
• Review of non-routine repairs.
• Assess new equipment for qualification.
• Provide quality oversight of new supplies ordering.

Training

• Mentor and train staff as appropriate.
• Cross train in other QC-Validation team functions.
• Cross train in use of lab equipment as necessary.

Professional Development:

• Complete required training in a timely manner (includes MasterControl, live company trainings, New Employee Orientation, etc.)

Regulatory Compliance:

• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
• Know and follow company policies and procedures.
• Complete required training on time.

Professionalism

• Attend work regularly and reliably.
• Adhere to all policies and procedures.
• Perform other duties as assigned

Competencies of this position

• Attention to detail.
• Ability to follow written instructions.
• Must have verbal and written communication skills.
• Legible handwriting
• Customer service skills
• Project management skills
• Advanced math skills required.
• Must be able to multi-task and be self-motivated.
• Time management- must be able to respond to voicemails, emails, and other communications in a timely manner.
• Computer skills: knowledge of Microsoft Office, email and internet usage.
• Communication skills: good verbal communication a must, proficiency in writing techniques a plus.
• Ability to work independently.
• Regular and reliable attendance required

Work Environment:
This job operates in a professional office and laboratory environment. This role routinely uses standard office equipment such as computers, keyboards, computer mouse, telephones, photocopiers, projectors and file cabinets.
Occasional travel during the business day. Some out-of-the area and overnight travel may be expected. May be required to attend trade shows, seminars and conferences in addition to sales travel.

Physical requirements:
Must be able to stand/walk for 30% of the day and 70% of the day sitting at a desk or on the computer. Must be able to occasionally lift a maximum of 45lbs.

Education and experience requirements:
(microbiology or biological science strongly preferred)
A.A./A.S. and four years of applicable experience OR B.S./B.A with at least two years of applicable
experience AND any one of the following:

• M.S.
• ASQ certifications
• Master Trainer certification

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.