Grifols Shared Services North America, Inc Sr Process Development Engineer I in Clayton, North Carolina
Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
Senior Process Development Engineer I
The incumbent will provide technical or scientific expertise and leadership to the development, scale-up, clinical manufacturing, transfer, and/or support of production processes for plasma derived protein therapeutics. Technical competencies are centered on unit operations such as filtration, precipitation, phase separation, chromatography, lyophilization and fill-finish. Effective project management, collaboration, critical thinking and problem solving skills are essential on cross-functional teams and supervisory responsibility for up to approximately 6 scientists, engineers, or technicians are anticipated.
Primary Responsibilities for Engineer I role:
• Responsible for independently identifying action plans to support departmental objectives.
• Execute action plans independently, as part of a team, or as the lead for a departmental team.
• Independently prepares and edits procedures or technical reports of a complex nature, including data interpretation, suitable for inclusion in IND, BLA, or equivalent regulatory submission.
• May communicate functional area and departmental results in cross-functional settings.
• Develops innovative solutions to complex technical problems and leads others in problem solving efforts.
• Independently designs, executes, and interprets results for novel and scientifically rigorous experiments. May direct others in study execution.
• Supports the execution of start-up and commissioning of equipment and processes.
• During technical transfer, provides technical review of design documents for assigned systems.
• Ensures scalability of unit operations during process development and can anticipate equipment related scaling issues.
• May be accountable for cGMP facility maintenance and operation.
• May lead drug product group responsible for process development and manufacturing in formulation, filling, and lyophilization activities.
• Maintains laboratory and clinical manufacturing facilities in accordance with procedure.
• Provides and/or supervises support for developmental studies, clinical or commercial manufacturing as needed.
• Identifies, implements, and qualifies, as necessary, equipment to achieve operational needs in compliance with regulatory expectations.
Knowledge, Skills and Abilities:
• Project management experience with strong ability to set and meet deadlines, multitask and prioritize resources based on project needs.
• Demonstrates critical judgment and strategic thinking sufficient to represent functional area concerns on cross-functional teams.
• Must have advanced written communication and excellent oral communication skills.
• Strong ability to creatively apply scientific or engineering principles in problem solving in potentially novel areas.
• Understands and applies standardized root cause analysis, investigation tools and methodologies.
• Has extensive knowledge in professional field of specialization (e.g., purification, formulation, fill-finish process analysis) and can mentor/train junior staff in relevant principles and/or guidelines.
• Has knowledge of cGMP and application to clinical manufacturing.
• Demonstrated leadership skills and ability to drive results.
• Ability to effectively collaborate and build alignment to achieve departmental objectives.
• Experienced in identifying projects risks.
Bachelor’s degree in Chemical, Biochemical, or relevant Field with a minimum of 5 years’ experience.
Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent 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. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. 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 and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 71669
Type: Regular Full-Time
Job Category: Research & Development