Senior Process Engineer - Bio-Processing

Senior Process Engineer - Bio-processing

Contract: 9-month contract role

Location: Madison, WI

Shift: Normally work 1st shift but may require to work other shifts and weekends if the project requires

Job Summary:

Our client is currently seeking an experienced Senior Process Engineer with bioreactor and a minimum of 10 years of life sciences experience to support projects in central Wisconsin. The selected engineer will lead bioreactor automation, process optimization, and scale-up projects. In addition, the selected candidate will provide technical support for risk assessments, change controls, SOPs, and batch records.

Job Description:

This role will be responsible for supporting process and automation engineering groups in upgrading and optimizing bioreactor bio-manufacturing processes in support of increased throughput and reduced batch times. The selected candidate will have the following responsibilities:

Coordinate, communicate, and oversee all aspects of project process design with internal/external design partners including but not limited to Client(s) and stakeholders, third-party engineering partners, construction partners, equipment & machinery suppliers, and other participating engineers and designers.

· Provide input on scale up strategies

· Draft risk assessments

· Author change controls

· Update affected SOPs

· Update affected batch production records

· Review and update manufacturing recipes

· Review alarm and set point limits

· Pareto data of alarms generated

· Platform acceptance criteria to ensure all alarm values require an actionable response or represent a risk to the process

· Review of procedures and systems to associated with alarms

· Implement new alarm strategies into product recipes

Requirements

Qualifications:

· A Bachelor’s or Masters of science degree in Engineering or Science is required.

· 10+ years of experience in life sciences engineering is required.

· Experience working in FDA/cGMP compliant environment required.

· Knowledge and application of biomanufacturing product and process development

· Ability to provide technical leadership in problem-solving and decision-making

· Ability to constructively challenge cross-functional project teams and business partners to achieve project goals.

· Strong collaboration, communication, and presentation skills required.

· Expert-level proficiency with Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.

Preferred Experience Requirements:

· Delta-V experience

· TrueBio experience

Job Type: Contract

Pay: $42.50 - $55.00 per hour

Expected hours: 40 per week

Benefits:

• Dental insurance
• Flexible spending account
• Health insurance
• Paid time off
• Referral program

Work setting:

• In-person

Education:

• Bachelor's (Preferred)

Ability to Relocate:

• Madison, WI 53717: Relocate before starting work (Required)

Work Location: In person