Associate Engineer, MS&T

Location
Rockville, MD, US
Posted
May 27, 2021
Ref
718488200
Hotbed
BioCapital
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.

I. JOB SUMMARY

The Associate Engineer, MS&T will support process validation activities and process transfer as a member of the Technical Transfer Process (TTP) Team which is a part of the Manufacturing Science & Technology (MS&T) Department supporting the contract manufacturing business unit. The individual will primarily be responsible for supporting multiple technical transfer projects for the aseptic fill and finish of pharmaceutical and biological drug products. Responsibilities include conducting experiments/studies, authoring protocols (e.g., engineering runs; process performance qualifications), reviewing and analyzing complex data, and authoring process validation protocols and reports. Support the development of manufacturing production records.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Contributes as a technical lead for process development in a team setting. Collaboratively design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer.
• Contributes to design studies for evaluating the robustness of the manufacturing process. These studies will serve as a baseline for the further process validation activities.
• Independently evaluates process data and perform in-depth analysis using scientific principles for evaluation of critical process parameters governing the performance of the process. Exercises judgement in selecting methods, techniques and evaluation criteria.
• Works with client's lead technical staff, department management and senior management to evaluate complex technical details pertaining to the project and defines the scope of the project.
• Collaborates with analytical, production, quality and project management team and ensure timely completion of project deliverables.
• Collaborates to review and analyze complex process data from the clinical and commercial manufacturing batches for conformity and facilitate batch release.
• Works collaboratively to provide guidance to lower-level personnel or as a team member.
• Executes QbD experiments to support the development and characterization of new manufacturing processes.
• Assists in multiple cross-functional projects that may require regulatory submissions.
• Effectively presents complex technical information to guide decision making.
• Independently author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
• Provides technical support for fill finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization.
• Performs periodic review of processes/systems.
• Writes and revises SOPs and Master Plans.
• Applies CGMP and CGDP to all areas of work.
• Supports the development of manufacturing production records and protocols for execution in support of qualifications, developmental/technical transfer projects, or for clinical and commercial manufacturing.
• Provides training to production/laboratory staff for protocol requirements and new manufacturing processes.
• Works with individuals at all education/experience levels and with multiple departments (production, laboratory, engineering, materials management, etc.)
• 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. degree required, preferred in Science or Engineering, with a minimum of 3 years of related job experience.
• High level of personal accountability and responsibility.
• Basic understanding of process design principles.
• Experience with drug product manufacturing processes development, process scale-up and optimization.
• Ability to perform well under tight timelines and excellent decision-making quality under pressure is desired.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Data evaluation and interpretation, including statistics and process controls.
• Experience and knowledge of sterile processing principles (aseptic or isolator technology).
• Training and experience working in a BSL-2 facility is a plus.
• 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 with multiple departments and experience/educational levels.
• Proficient knowledge of CGMP.
• Previous expertise with fill/finish operations, aseptic and/or isolator manufacturing, process validation/process performance qualifications, and technical writing are preferred for this role.
• The individual must also have excellent communication skills, both written and verbal.

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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