BioProcess Engineer I

Responsibilities:

• Execution of all assigned activities according to production schedule and in compliance with the valid GMP, work, operating, environmental and safety instructions and guidelines.
• Assist in manufacturing led investigation through partnerships with Quality and other business units at the site.
• Produces product, learns to troubleshoot equipment, participate in interviews on deviations, stocking of items in production, and standardizing equipment.
• Learn aseptic techniques, cell culture, recovery, and purification processes within Upstream manufacturing.
• Assists in producing clinical and commercial material on an annual basis that meets the site’s strategic objectives and is compliant with cGMPs.
• Supports product requirements to ensure that all products are produced according to plan. Learn cGMP and cGDP and ensure cGMP documentation is being filled out correctly, training is current, and all Quality requirements are being followed.
• Maintains quality standards to meet cGMP requirements, CFR’s, and internal company policies directly related to the manufacturing process.
• Partners with Quality to ensure a quality and compliant manufacturing environment and assists the technical operations team to resolve any issues related to production.

Requirements:

• Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field or 2 years equivalent experience.
• Excellent oral and written communication skills.
• Entry level into the biopharmaceutical based GMP manufacturing operations, no experience necessary.
• Ability to routinely lift over 35 lbs.