Senior Associate Process Development Engineer II / Process Development Engineer

Grifols, S.A; Clayton (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company dedicated to enhancing healthcare globally. As a Senior Associate Process Development Engineer, you will leverage your expertise in plasma-derived proteins to drive innovation in production processes. Your role will involve designing and executing experiments, troubleshooting complex issues, and ensuring compliance with stringent GMP standards. Collaborate with a dynamic team to make a meaningful impact on the health and well-being of millions. This is an exciting opportunity to be part of an organization that values your contributions and supports your professional growth.

Qualifications

• 7+ years of relevant work experience in process development.
• Experience working in a GMP environment and technical writing.

Responsibilities

• Support developmental and manufacturing projects.
• Prepare technical reports and analyze data.
• Conduct laboratory work and maintain cGMP standards.

Skills

Technical Writing

Chromatography

Filtration

Problem Solving

GMP Knowledge

MS Office Suite

Education

Bachelor’s Degree in Science or Engineering

Associate's Degree with Experience

Job description

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Senior Associate Process Development Engineer II / Process Development Engineer

Location:

NC-Clayton, US

Contract Type: Regular Full-Time

Area: Research & Development

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

The incumbent will provide technical and scientific expertise to the development, scale-up, transfer, and/or support of production processes for plasma derived proteins. Activities are centered on purification unit operations such as precipitation, filtration, chromatography, tangential flow filtration, formulation, nanofiltration, and process troubleshooting.

Primary Responsibilities :

• Supports developmental projects, manufacturing support projects, clinical manufacturing, and commercial manufacturing.
• Identifies or assists in developing action plans to support departmental goals and supports the execution.
• Prepares procedures and technical reports, including data analysis and interpretation.
• Prepares and/or reports technical results in internal and cross-functional team settings.
• Develops solutions to complex technical problems within area of expertise.
• Designs and executes scientifically rigorous experiments including the interpretation of results.
• Ability to execute experiments independently and in a team setting which may include the ability to direct others and lead study execution.
• Conducts laboratory and clinical production work using standard processing and analytical equipment.
• Identifies and collects data on critical process attributes and/or critical parameters for scaling.
• Supports the start-up and commissioning of equipment as well as implementation of new raw materials on-site.
• Supports the maintenance of the clinical manufacturing facility to cGMP standards.
• Maintains laboratory and clinical manufacturing facilities in accordance with departmental procedures.

Knowledge Skills and Abilities :

• Possesses the ability to set and meet deadlines, multi-task, and prioritize personal objectives based on project needs.
• Exhibits the ability to adapt to a changing work environment.
• Must have experience in technical writing, which may include laboratory notebook maintenance, and effective oral communication skills.
• Applies scientific or engineering principles in problem solving.
• Must have experience working at various process scales ranging from bench to pilot scale.
• Has knowledge and experience working in a GMP environment.
• Considerable knowledge in area of specialization (i.e. chromatography, filtration, etc.) and/or takes initiative to stay current and expand knowledge base.
• Must be self-motivated and able to work effectively in a matrixed organization.
• Must be proficient in use of MS Office Suite.

Location: Clayton, NC

Shift: Day

Education and Experience :

Bachelor’s degree in a relevant science or engineering field with 7+ years of relevant work experience, Associates Degree with 9+ years of experienceoran equivalent combination of education and experience

Occupational Demands For Engineer:

Work is performed in a clinical and/or a laboratory environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently works with diverse groups to obtain consensus on complex issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.