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 candidate will support validation activities as a member of the Engineering Team. The candidate will primarily be responsible for developing protocols and executing IOQ, and PQ activities. These activities are related to periodic re-validations, new projects, and new product introductions (Tech Transfers). Responsibilities include designing experiments/studies, authoring protocols (e.g., engineering runs; IOQ/PQ), reviewing complex data, and authoring validation reports. Previous expertise with fill/finish operations, process validation, and technical writing are critical to this role. Candidate must also have excellent communication skills, both written and verbal.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Act as key technical lead for IOQ, and PQ protocol development. Independently author and manage execution studies for existing and new equipment, utilities, and process development.
- As part of the tech transfer for new products, independently design studies for evaluating the robustness of the process. These studies will serve as a baseline for the process validation activities.
- Independently evaluate data and perform in-depth analysis using scientific principles for evaluation of critical process parameters.
- Exercises judgement in selecting methods, techniques and evaluation criteria.
- Works with internal and external customers to evaluate complex technical details pertaining to the project and defines the scope of the project.
- Function as the SME for validation processes and Technical Transfer of new products for validation.
- Collaborate with cross-functional team and ensure timely completion of project deliverables.
- Work independently and provide guidance to lower level personnel or as a team member.
- Independently manage multiple cross-functional projects that may require regulatory submissions.
- Effectively present complex technical information to guide decision making.
- Independently author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
- Provide technical support for fill finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization
- Perform periodic review of processes/ systems.
- Write and revise SOPs and Master Plans biennially or as part of process improvements.
- Apply CGMP and CGDP to all areas of work.
- Requires vaccination against different viruses including Vaccinia virus.
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
B.S. in Science or Engineering with a minimum of 7 years job experience.
- Strong leadership skills; high level of personal/departmental accountability and responsibility.
- Strong understanding of process design principles.
- Experience with drug product manufacturing processes and sterile processing
- Ability to perform well under tight timelines and excellent decision making quality under pressure
- Ability to manage multiple priorities and tasks in a dynamic environment.
- Excellent written and communication skills
- Ability to exercise judgment to determine appropriate corrective actions.
- Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
- Ability to work in a team environment.
- Proficient knowledge of CGMP.
- Coordinate multiple tasks simultaneously.
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.