Emergent Biosolutions Hiring for Analyst III, QA Validation at Winnipeg, MB Full Time

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

ANALYST III, QA VALIDATION

Emergent BioSolutions is currently seeking an Analyst III, QA Validation for our Winnipeg site. The successful candidate will have a bachelor’s degree in a related field, accompanied by over 5 years of functionally related experience and experience in a pharmaceutical manufacturing environment or in a similarly regulated manufacturing environment. The ideal candidate will possess strong organizational and interpersonal skills and the ability to work collaboratively with personnel at all levels of the organization. Must have a strong working knowledge of data integrity principles and use of risk assessment and demonstrated success in technical proficiency and collaboration with others. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

THE COMPANY

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

THE OPPORTUNITY

The Analyst III, QA Validation supports broad ranging responsibilities in routine Validation maintenance and project related Validation and qualification activities. The position is responsible for reviewing and approving test documentation and reports and provides guidance to internal team members to ensure all documentation meets internal procedure and applicable regulatory standards. The position will support all disciplines within Validation: including Commissioning and Qualification, Cleaning Validation, Computer Systems Validation, Process Validation, Method Validation and Validation Maintenance.

DUTIES & RESPONSIBILITIES

Responsible for reviewing and approving all qualification and validation documentation including deficiencies initiated during testing activities.

Responsible for reviewing and approving supporting documentation like Specification Documents and System Level Impact Assessment Reports.

Provide QA validation support and guidance to major capital projects and corporate initiatives that are being implemented in Winnipeg site.

Assist in the implementation of any existing validation program to ensure continued compliance to the necessary regulations.

Maintain effective communication with other validation groups to ensure that project goals and objectives are aligned.

Participate in the development of validation activities associated with new equipment, processes or system upgrades.

Participate in cross-functional teams to achieve site goals.

Responsible for performing administration functions, generation of standard operating procedures, and review of maintenance work instructions as required.

Responsible in reviewing change management proposals as per procedure.

Responsible in reviewing and approving unscheduled work orders to ensure that the system will maintain its validated state.

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:
Bachelor’s degree in a related field, accompanied by over 5 years functionally related experience (or an equivalent combination of education and experience)

Experience in a pharmaceutical manufacturing environment or in a similarly regulated manufacturing environment preferred.

Possesses strong organizational and interpersonal skills and the ability to work collaboratively with personnel at all levels of the organization.

Possess strong knowledge of Project Life Cycle and quality systems, cGMP, and regulatory guidelines and good engineering practices such as ISPE guidelines.

Skilled or has expertise in key validation areas such as CSV, C&Q, Sterilization, temperature mapping, aseptic process simulations, cleaning, process and method validation.

A strong working knowledge of data integrity principles and use of risk assessment methodology is required.

Demonstrated success in technical proficiency, and collaboration with others.

Excellent attention to detail, with an ability to work to very tight schedules.

Strong knowledge in use of Microsoft Office suite is required.

Excellent communication and organizational skills.

ADDITIONAL REQUIREMENTS:
Citizenship/Permanent Resident or Valid Work Permit.

Successful Completion of a Criminal Record Check.

Medical Assessment required upon hire

Interested? Please visit www.emergentbiosolutions .com under the career section to apply today!

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 .