Experienced Engineer - Cleaning Validation

Description

The company is expanding its manufacturing capacity with a $2 billion investment in a new facility in Wilson, North Carolina. The site will produce innovative biologic medicines for oncology, immunology, and neuroscience, and the investment supports a steady future supply of medicines as demand grows.

You will join the Manufacturing Science and Technology (MSAT) team, which sets the process technology platform strategy for biotherapeutics made in the new Bioprocessing Facility. The team handles process and cleaning validation, standardizes equipment for new product introductions, and manages the life cycle of commercial production processes.

This is an Experienced Engineer role in the MSAT Cleaning Validation group, based in Wilson, NC, in the Process Engineering sub-function of Supply Chain Engineering.

Responsibilities

• Carry out MSAT work in line with US and EU regulations, local and global procedures, and EHS&S requirements.
• Lead most of your time on cleaning validation: cleaning cycle development, performance qualifications, clean hold studies, and requalification runs.
• Write MSAT documents such as protocols, procedures, and reports, and manage their review and approval.
• Review and approve documents written by other MSAT colleagues.
• Run MSAT protocols in the field.
• Support manufacturing with routine operations and project work when needed.
• Gather information from contractors, suppliers, and other departments to write technical reports.
• Track and close exceptions, events, and nonconformances that come up during MSAT work.
• Set MSAT priorities to match the manufacturing and project schedules.
• Coordinate MSAT tasks with contractors and vendors as required.
• Complete assigned training needed to take on the Senior MSAT Engineer role.
• Join multi-functional project and investigation teams as required.

Requirements

• A degree in Life Sciences, Engineering, Biology, Biochemistry, or a related scientific field.
• At least 3 years of experience in pharmaceutical manufacturing, or an equivalent background.
• At least 2 years of experience in biological cleaning validation.
• Strong verbal and written communication skills, with the ability to work well with internal and external customers.
• Strong computer skills, including MS Office, Excel, and SAP.
• The ability to work independently with minimal supervision and still meet tight deadlines.
• The ability to deal with people at different levels of the organization, perform under pressure, and resolve conflicting priorities.
• The ability to work on your own under general direction, set priorities, and manage your time well.
• The ability to lead a multi-functional team and handle complexity and change.
• Working knowledge of FDA, EMEA, and other regulatory authority requirements.
• Beneficial, not required: experience in projects, process validation support such as mixing studies, microbial hold studies, and media challenges, thermal validation, process improvement projects, and new product introduction or process validation support.
• Preferred skills: analytical reasoning, computerized equipment skills, emerging technologies, Gemba Kaizen, issue escalation, Lean supply chain management, problem solving, process control, process engineering, process orientation, product improvements, STEM application, situational awareness, supply planning, technical research, being technologically savvy, and validation testing.

Conditions

The base pay range for this position is 79,000-120,000.

The role is located in Wilson, North Carolina, United States of America.

The company gives equal opportunity to all applicants, and interview accommodations can be requested through the listed support resources.

Benefits

• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year, or 56 hours for employees living in Washington State.
• Holiday pay, including floating holidays: 13 days per calendar year.
• Work, personal, and family time: up to 40 hours per calendar year.
• Parental leave: 480 hours within one year of the birth, adoption, or foster care placement of a child.
• Condolence leave: 30 days for an immediate family member and 5 days for an extended family member.
• Caregiver leave: 10 days.
• Volunteer leave: 4 days.
• Military spouse time off: 80 hours.
• Eligibility depends on the applicable policies and date of hire.