Upstream Manufacturing Associate I Jobs

Operation and understanding of word processing, spreadsheets, and data management

Knowledge of GMP and safety requirements.

An equivalent of 1 – 2 years of biologics industry experience required

Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes

Knowledge of biotechnology operations such as, Aseptic Filtration Systems, Fermentation Process, Inoculation Process, Chromatography Columns, TFF step etc.

1 – 2 years of biologics industry experience required

Basic knowledge of buffer solution preparation or purification processing is preferred

Experience in single-use platform technology is preferred

Excellent written and verbal communication skills are required

Energetic, motivated and dynamic individual.

Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Collaborate with the Engineering teams on BOM/Change Management control and help administer PLM (Product Lifecycle Management) system.

Expected annual salary: 88k (subject to adjustment for relevant experience, skills, geo location)

1-3 plus years’ experience as an electronics engineer, including test experience

Minimum of 1 year experience in debugging and troubleshooting at the PCBA level

BS in Electrical Engineering, Electronics OR equivalent industry experience

Hands on experience with lab equipment such as multimeters, oscilloscopes, power supplies, and AC/DC Loads

And more benefits that come with working for a global industry leader!

5 years or more, with experience in manufacturing.

Hourly pay starting from $16.50/hr

Tuition Assistance & Employee Discounts

Must be 18 years of age

Required to work a 12 hour work schedule

Environmental Management Systems (EMS), and other regulatory requirements.

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),

An equivalent combination of education and work experience

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies,

0-3 years relevant engineering experience

Demonstrated experience with CAD systems. Basic understanding of mechanical reasoning, physics, electronics, metal working and plastics.

Experience in a fast paced, iterative design environment within marine, automotive, aerospace or similar industries

Experience with 3D CAD software such as NX, Solidworks, Fusion 360, Catia etc.

Bachelor’s degree in mechanical, manufacturing or similar engineering field or equivalent experience in field

Experience with NX and TeamCenter

At least 2 years professional experience in a manufacturing/ production engineering type role

Competitive benefits including excellent medical, life insurance, 401k plan

Proactively works with senior associates, subject matter experts, and management to achieve training competency in production operations

Required 0-2 years related experience

Good organizational and communication skills, both written and verbal, and the ability to prioritize competing tasks

Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices

Completes setup, use, and cleaning (as necessary) of cGMP production equipment

Ensures work executed in compliance with company and regulatory quality policy and systems

Support experiments to test hypotheses based on in depth knowledge of process specialty

Assist in editing and/or reviewing standard operating procedures, technical reports and qualification/validation documentation

Bachelor’s degree or equivalent in Biochemistry, Chemistry, Engineering or a closely related field with one year of experience is required

Direct experience in protein process development function such as analytical, cell culture or protein purification

Knowledge is required in the methods of one or more of these specialties

Knowledge of GMP and GLP regulations

Perform all other duties as assigned by supervisor or manager.

At least 1 year of mammalian cell culture experience (suspension or adherent) after undergrad.

Strong work ethic, communication skills and goal-oriented personality.

Demonstrable experience keeping pristine records of experiments and DNA constructs produced using a digital laboratory notebook.

Strong problem-solving and critical thinking skills.

Experience with suspension cell culture.

Every employee is responsible for performing the job safely and for calling to management's attention unsafe conditions, practices, or equipment

Working experience with GMP in a highly regulated industry

Performs routine engineering assignments of related tasks which are typically a focused portion of larger projects

Assist in the design of production equipment and fixtures

Work with cross-functional project teams to complete Sustaining/Technical Cost Out engineering projects from planning through implementation.

Work with design owners as needed to mirror documents in the local ERP system.

Maintain records to comply with regulatory requirements and performs daily in-process testing.

Maintain daily workload schedule and relevant resource requirements.

Knowledge of cell culture process steps including cell banking, thaw and expansion, production, and harvest.

Experience with manufacturing of bulk drug substance following SOPs and batch records within a cGMP regulated environment.

Perform a variety of complex tasks under general guidance and in accordance with current GMPs.

Draft, execute, document, and review data, and approval of SOP's and batch records according to GMP guidelines.