Bioprocess Specialist

Location
Lansing, MI, US
Posted
Feb 19, 2021
Ref
706860600
Required Education
Bachelors Degree
Position Type
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.

JOB SUMMARY
The Bioprocess Specialist is responsible for organizing, sustaining, and continuously improving the manufacturing operations processes. Responsibilities of primary importance are timely completion of quality systems work to ensure on-time delivery of product to the customer while driving continuous improvement and operational excellence.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Author major, minor and critical investigations
• Develop change control strategies for routine projects and improvement initiatives
• Write and revise all types of controlled documentation
• Execute quality systems work in accordance with site/department goals and standards
• Participate as manufacturing representative on project teams while effectively involving SMEs
• Apply lean manufacturing tools and methodologies for the progression of process improvements (6S, Kaizen, A3, Value Graph, Kata, etc.)
• Participate in site regulatory and internal audits
• Train manufacturing operators on new processes and major process changes
• Mentor operators on entry level quality systems initiation/authorship
• Member of a Tier 2 integrated process team supporting quality system work, continuous improvement and driving action for the cross-functional team

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education:
• Bachelor's degree in Engineering, Life or Physical Sciences or commensurate experience

Experience:
• Minimum 2 years of experience working within the quality systems (deviation, CAPA, Change Control)

Knowledge:
• Current GMP's, international regulatory requirements and guidelines
• Root cause analysis tools such as fishbone, 5 whys, etc.
• Familiarairty with risk assessment concepts
• Technical writing principles

Skills:
• Can perform at an intermediate level in Excel and Word, with a basic understanding of PowerPoint and Visio
• General understanding of SAP

Abilities:
• Effective verbal and written communication within current level and below
• Able to manage multiple priorities while meeting required timelines
• Able to differentiate between compliance and business risk
• Ensure own accountability while working on cross-functional integrated teams
• Proficient at use of root cause analysis tools within quality systems

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.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

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 .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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