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.
ASSOCIATE SPECIALIST, VALIDATION
Emergent BioSolutions is currently seeking an Associate Specialist, Validation in Winnipeg. The successful candidate will have a bachelor’s degree in a related field accompanied by at least 5 years’ experience. The ideal candidate will have experience in the pharmaceutical industry or in a similarly regulated manufacturing environment. The ideal candidate will have strong communication, organizational and interpersonal skills as well as the ability to work collaboratively with personnel at all levels of the organization. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.
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.
Broad Ranging role that supports both routine validation maintenance activities and project related commissioning and qualification activities. This role includes authoring, reviewing, and executing test documentation with responsibility for leading and coordinating activities with cross-functional teams to achieve completion of relevant testing.
DUTIES & RESPONSIBILITIES
Responsible for preparing and executing validation test documentation (IQ/OQ/PQ), for the validation of new and existing equipment and systems.
Involved with all phases of the validation lifecycle; from design, commissioning, FATs, SATs , and qualification, to validation maintenance.
Apply cGMP guidelines to all aspects of validation.
Review User Requirement Specifications and change management proposals.
Write summary reports, following good documentation practices.
Assist in the closure of deficiencies initiated during testing activities.
Support implementation of existing validation program to ensure activities are completed as per schedule, and in continued compliance to the necessary regulations.
Coordinate activities with cross-functional teams and m aintain effective communication for reporting status of assigned tasks.
Provide technical support as a subject matter expert for processes and equipment.
Develop testing strategies and rationale for equipment and systems.
Analyze statistical data to verify acceptable criteria.
Lead execution of capital and validation projects, as assigned.
Support administration functions, create and update standard operating procedures, and review maintenance work instructions.
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 at least 5 years functionally related experience, or an equivalent combination of education and experience.
Experience in pharmaceutical or similarly regulated manufacturing environment. Aseptic/sterile manufacturing or qualification experience within the biopharmaceutical industries is preferred.
Possesses strong communication, organizational, and interpersonal skills, as well as the ability to work collaboratively with personnel at all levels of the organization on tight schedules.
Familiar with CSV/GAMP, 21 CFR Part 11, Annex 11, cGMP, GDP, FDA/EMEA, project life cycle and quality systems.
Possess strong ability to apply regulatory guidelines and good engineering practices, such as ISPE guidelines, to all aspects of validation activities.
Demonstrated ability to successfully lead capital and validation projects.
Expertise in key validation areas such as computer systems, critical utilities, facilities, sterilization, temperature mapping, and cleaning validation, preferably in a GMP environment.
A strong working knowledge of data integrity principles and use of risk assessment methodology is required.
Demonstrated success in technical proficiency and attention to detail.
Knowledge in use of Microsoft Office suite is required.
Citizenship/Permanent Resident or Valid Work Permit.
Successful Completion of a Criminal Record Check.
Interested? Please visit www.emergentbiosolutions .com under the career section to apply today!