Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

This role will be primarily focused on Electronic Batch Record implementation as the Product Owner as well as managing the Frederick site's Digital Daily Tier Management (DDTM) system.

EBR/MES Product Owner Responsibilities

• Prioritizes and synthesizes backlog with business leads input
• Understanding of how batch records are used in manufacturing, QC and QA processes
• Understanding of data mapping of data sources (applications and equipment) to TrakSYS
• Represents and speaks on behalf business/priorities with business leads input
• Product Ownership for the life of the program and post implementation.
• Tactically focused
• Responsible for creating a vision so that the development team can clearly visualize the expected outcome by the user
• Interact and collaborate with the users to understand their requirements
• Act as a primary liaison between the teams and the users; ensure the goal and the vision are correctly aligned with the work items on the product backlog 
• Ensure Development works/delivers per the priorities, and monitor the progress of the items over the course of a sprint 
• Participate in daily SCRUMs, Backlog Grooming, Sprint Planning Meetings, Sprint Reviews, and Retrospectives
• Attend other meetings as needed ​

Digital Daily Tier Management Responsibilities:

• Training and driving implementation of roll-out to the site
• Setting up a manufacturing execution system
• Leads building of improvements on current system and roll out to the site
• Manages intake of support questions and reassigns to technical team when applicable
• Manages role assignments
• Translates Daily Tier Management processes and activities to how the system supports those processes
• Owns the understanding and documentation of data mapping from data sources to the presentation of data in DDTM
• Partners with the technical team on data migration

Requirements:

• Bachelor’s degree in a science, engineering or related field with 4+ years of manufacturing experience in an FDA regulated environment or equivalent OR 10+ years of manufacturing experience in an FDA regulated environment or equivalent without a bachelor’s degree.

Strongly Preferred:

• 1+ years experience working with electronic batch records in an FDA regulated environment
• Excellent communication and presentation skills for stakeholder engagement
• Demonstrated ability to work effectively in a matrix organization
• Ability to collaborate effectively with cross-functional teams
• Strong problem-solving and analytical thinking skills

Preferences:

• Expertise in cGMP and GDP
• Experience with developing user stories as part of software development
• Prior experience with Agile methodology
• Lean manufacturing or Lean Six Sigma experience
• Advanced proficiency in digital platforms (Google Analytics, Adobe Analytics, Power BI)
• Experience with Low Code platforms
• Experience with data analysis and visualization tools for performance tracking and reporting

Compensation and Benefits

The salary range estimated for this position based in Maryland is $83,300.00–$100,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards