Digital Operations Associate, Downstream
About the role
Help power safe, efficient, and fully digital manufacturing. You’ll support tools enabling recipe-driven production, electronic batch execution, and data integrity in a cGMP environment. Collaborate across Manufacturing, Automation, and Quality to keep life-changing therapies moving.
Responsibilities
- Execute assigned tasks to deploy and sustain digital manufacturing tools (e.g., MES, data historians, electronic logbooks).
- Absorb and prepare documentation for review and approval in recipe-driven operations.
- Collect, analyze, and monitor basic data to support reliable digital operations.
- Follow cGMP and data integrity standards; escalate non-routine issues promptly.
- Support user training by preparing materials, documenting standard work, and conducting guided walkthroughs.
- Participate in cross-functional coordination to enable digital integration and electronic batch execution.
- Contribute to continuous improvement by identifying opportunities to streamline tasks or standard work.
- Provide on-call support participation as scheduled, with guidance from senior staff.
- Maintain accurate records, logs, and status updates for assigned tasks.
Requirements
- High school diploma/GED with 4 years of related experience; Associate’s degree in Life Sciences or Engineering with 2 years of related experience; Bachelor’s degree in Life Sciences, Engineering, Information Systems, or related field; or equivalent practical experience.
- Willingness to support a 24/7 manufacturing environment as needed, including rotational on-call.
- Foundational understanding of cGMP and data integrity principles.
- Strong attention to detail, organization, and time management; clear written and verbal communication.
- Basic problem-solving skills and the ability to follow standard procedures, escalating when appropriate.
Qualifications
- Bachelor’s degree in Life Sciences, Engineering, or related discipline.
- Experience (internship, co-op, or project) supporting digital manufacturing systems such as MES, PI/data historian, DCS/PLC, LIMS, or ERP integration.
- Familiarity with GMP/GLP requirements and biological manufacturing environments.
- Foundational knowledge of MES and electronic batch documentation; ability to learn digital systems quickly.
- Experience collaborating cross-functionally with Manufacturing, Quality, and Automation.
Skills
Not specified
Benefits
Competitive pay with opportunities for growth and skill development
Comprehensive health and wellness benefits (medical, dental, vision)
Employee support resources
Retirement savings plan with company contribution
Paid time off and company holidays
On-call compensation where applicable
Education assistance, professional development, and training on digital manufacturing systems
Inclusive, team-centered culture focused on safety, quality, and continuous improvement
Equal Opportunity Employer
Pay
Not specified
Schedule
Not specified