Production Specialist

Work Location: Round Rock, Texas
Shift:
Department: LS-SC-PUKU Ops Catalogue
Hiring Manager: James Kiesow

This information is for internals only. Please do not share outside of the organization.

Your Role

The Project Specialist, Manufacturing Support is responsible for evaluating new technologies and manufacturing processes for Round Rock catalog and private label customer specific product formulations and aliquots. Specific responsibilities include:

• Assist in coordinating production schedules using in-depth knowledge of project requirements.
• Evaluate new technologies and participate in new product design
• Assist in writing technical documents such as batch records, forms, procedures, and reports
• Assist in reviewing and resolving non-conforming work or deviations from MilliporeSigma standard operating procedures, including writing corrective and preventive action reports
• Assist in training technicians on quality documentation practices, project initiations, laboratory maintenance, and the safe operation of laboratory equipment
• Critically assess the team's performance against production schedules and drive process improvement
• Develop and schedule formulation workshops, proficiency events, and training video content
• Serve as a designee for the Laboratory Manager in the approval of controlled production records
• Order manufacturing raw materials for weekly scheduling based on standards published weekly and determine material availability
• Perform specified manufacturing processes to produce finished products meeting production goals
• Serve as a Project Lead and/or point-of-contact for specific projects, coordinating meetings, ensuring compliance with requirements, and managing materials
• Ensure the Laboratory is maintained in a state of "audit readiness," with a clean and organized work environment
• Perform all tasks in accordance with MilliporeSigma policies, procedures, and cGMP requirements, with current training records
• Maintain laboratories according to hazardous waste management practices and consult with the EHS Manager and Lab Manager on waste management procedures
• Communicate any issues and concerns to the Manager or Supervisor, especially when production targets are not achievable
• Understand and review all calculations used for production processes
• Review project design to ensure regulatory requirements are met
• Develop suggestions and ideas for continuous improvement of processes and procedures
• Write and review batch records and forms to support catalog and custom production
• Assist in training and mentoring staff through regular proficiency demonstrations and project-specific requirements

Physical Attributes:

• Lifting at least 30 pounds

• Exposure to hazardous chemicals such as flammable solvents, carcinogens, dioxins, and corrosives
• Wear PPE such as gloves, lab coat, safety glasses, respirators, face shields

Who You Are

Minimum Qualifications:

• Bachelor's Degree in Chemistry, Chemical Engineering, or other Life Science discipline
• 3+ years of work experience in a life science manufacturing environment

OR

• Associate Degree in Chemistry, Chemical Engineering, or other Life Science discipline
• 5+ years of work experience in a life science manufacturing environment

Preferred Qualifications:

• Basic understanding of Round Rock and customer products, their applications, and requirements
• Knowledge of MilliporeSigma quality systems for GMPs, GLPs, ISO, and other regulations
• Familiarity with departmental and company processes and goals
• Detail-oriented with strong verbal, written, problem-solving, and computer skills
• Proficient in drafting technical documents such as batch records, procedures, and reports.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.