Sr. BioProcess Specialist
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 Senior 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.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Lead/facilitate major and critical investigations and problem-solving initiatives
- Develop change control strategies for complex projects and improvement initiatives
- Write and revise all types of controlled documentation
- Monitor quality systems performance within the department and act on findings
- Act as sole manufacturing representative on project teams while effectively involving SMEs and management
- Apply lean manufacturing tools and methodologies for the progression of process improvements (6S, Kaizen, A3, Value Graph, Kata, etc.) and drives engagement of the use of these tools across the department
- Works closely with management to ensure quality system execution strategies are efficient and align to site key performance indicators
- Develops project plans including work scope, timeline and cost estimates for process improvements and cost savings initiatives
- Mentor less experienced peers and operators in quality systems and OE principles using situational based leadership
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor’s degree in Engineering, Life or Physical Sciences or commensurate experience
- Minimum 5 years of experience working within the quality systems (deviation, CAPA, Change Control)
- Current GMP’s, international regulatory requirements and guidelines
- Understanding of process and equipment validation requirements
- Root cause analysis tools such as fishbone, 5 whys, etc.
- Risk assessment tools such as FMEA
- Technical writing principles
- Can perform at an intermediate level in Excel, Word, PowerPoint, Visio
- General understanding of SAP
- Effective verbal and written communication at all levels of the organization
- Able to manage multiple priorities while meeting required timelines
- Proactive identification of risk and identification of risk-based solutions to problems
- Ensure accountability on cross-functional integrated teams
- Application of root cause analysis principles within and outside of the quality systems
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
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.