Analyst II, QA Validation

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life-saving solutions to
communities around the world.  Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Job Summary

The Analyst II, QA Validation supports the Validation team by contributing positively and accurately to the completion of all tasks within the related job. Follows standard operating procedures and contributes to the continuous improvement and regulatory compliance within the unit. Makes every effort to complete annual goals established by the department.

Responsibilities

• Write and execute validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc
• Write summary reports, following good documentation practices
• Use temperature monitoring devices such as the Kaye Validator and/or Ebro dataloggers to perform mapping studies
• Write/update SOPs
• Analyze statistical data to verify acceptable criteria
• Develop testing strategies and rationale for equipment/systems
• Provide technical support/troubleshooting for process and equipment issues
• Attend production and team meetings, as required
• Maintain close contact with manufacturing and laboratory departments to assure effective communication on issues related to validation
• Apply cGMP guidelines to all aspects of validation
• Investigate/resolve deviations associated with validation studies
• Assist with commissioning, FATs, and SATs.
• Other tasks as assigned. 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

• Attainment of a relevant university degree or technical diploma from a recognized post-secondary educational institution or an acceptable combination of education and experience.
• Minimum 2 years functionally related experience preferably in a pharmaceutical manufacturing environment or in a similarly regulated manufacturing environment.
• Demonstrated competencies include knowledge of validation principles and practices, strong organizational and interpersonal skills and the ability to work collaboratively with personnel at all levels of the organization.
• Must be able to work on multiple projects simultaneously
• Basic knowledge in use of Microsoft Office suite of products is required.

• Possesses Strong knowledge of Project Life Cycle and quality systems, cGMP, and regulatory guidelines and good engineering practices such as ISPE guidelines.
• Previous project experience within the pharmaceutical or biopharmaceutical industries is preferred.
• Equipment and Systems commissioning and qualification experience up to and including PQ.
• Demonstrates success in technical proficiency, and collaboration with others. 
• Excellent attention to detail, with an ability to work to very tight schedules.
• Excellent communication and organisational skills.
• Adaptable and flexible.
• Ability to pass pre-employment medical and background checks.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.