Work Schedule

12 hr shift/days

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

At Thermo Fisher Scientific, your work will make a difference in important areas such as finding cancer cures, environmental protection, and ensuring food safety. You'll have a real-world impact and receive support in achieving your career goals.

How will you make an impact?

Own the Steriles North manufacturing team providing technical, mechanical, and leadership to the operations activities in the assigned. Supervises operations employees of high-quality pharmaceutical products according to schedules, cost, and quality standards, while maintaining employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures.

Role and Responsibilities:

Help to ensure successful start-up of new Sterile facility by being a member of the site project team.

Ensures new processes/procedures are developed and implemented in a timely manner to coincide with daring project timelines.

Assists with building and training the production team that will staff the new Sterile Filling lines.

Leads assigned staff by: supporting organizational change, developing staff, building relationships, positioning staff for success, meeting career and interpersonal goals, forming effective teams, promoting engagement, and fostering motivation.

Collaborates with employees to ensure high-quality products that exceed cGMPs, spending at least 50% of available time.

Ensures that production schedule is met by distributing workload in accordance with changing priorities.

Ensures accurate batch documentation, SOPs, training, critical templates, equipment calibration, and housekeeping in all areas of responsibility for regulatory compliance.

Reviews operation problems, develops potential solutions, evaluates or tests solutions, and prepares summary reports/recommendations for management.

Assures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems.

Holds staff accountable and applies subject area process as required. Assists in hiring staff as needed. Maintains a work environment with nurture partnership and supports the company’s continuous improvement process.

Provides training and/or opportunities for career development of staff.

Education:

Bachelor’s degree in science, Engineering, Administration, or other STEM related program or equivalent experience is highly preferred.

Experience:

Minimum four (4) years of technical and/or manufacturing experience.

One (1) to five (5) years of supervisory experience preferred.

Equivalency: Equivalent combinations of education, training, and equivalent work experience may be considered.

Knowledge, Skills, Abilities:

Knowledge in GMPs and FDA regulations.

Technical writing experience preferred.

Technical and operational knowledge of start-up of aseptic environment for live virus vaccines

Strong decision-making skills.

Skilled in balancing multiple ongoing activities and the ability to prioritize tasks.

Outstanding attention to detail

Exudes the ability to maintain a high degree of confidentiality.

Excellent interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle urgent matters.

Highly effective verbal and technical written communication skills. Able to develop SOPs, work instructions and manufacturing process.

Proven track record to manage and lead professional staff in order to achieve goals, evaluate and resolve sophisticated technical problems.

Ability to empower, energize, and retain key staff by direct interactions with supervisors and staff.

Leads to set the example for others to follow

At Thermo Fisher Scientific, each one of our 100,000 outstanding individuals has an unusual story to tell. Join us and contribute to our outstanding mission—enabling our customers to make the world healthier, cleaner and safer!