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.
Discover Impactful Work:
Under the direction of the Process Manager, support daily operations and other technical aspects of simultaneous production in Manufacturing; resolve discrepancies, CAPAs, and engineering projects; drive continuous improvement in EH&S/Quality/Efficiency
A Day in the Life:
Provide oversight and technical expertise for daily Manufacturing operations (Troubleshooting, Changeover, Maintenance).
Generate Process Flow Diagrams, manufacturing procedures, recipes, and BDR specifications.
Support the Process Manager to meet production goals and requirements in a safe, compliant, and cost-effective manner.
Interact with internal and external customers to provide information in response to inquiries about products and services. Apply technical knowledge, expertise, experience, and good decision making to resolve manufacturing related problems, complaints, and quality related issues.
Make process improvement recommendations. Troubleshoot process/equipment and resolve issues.
Drive continuous improvement in EH&S/Quality/Efficiency to improve right first time in all areas. Proactively address safety, quality, housekeeping, and maintenance issues.
Review and approve lifecycle documents including P&IDs, criticality assessments, Quality Risk Assessments, Qualification Validation documentation, and EH&S Process Hazards Analysis. Ensure documents are accurate and current.
Partner with other departments to ensure all needed materials are available and released.
Create/update MBRs, cleaning procedures, and SOPs and review batch records.
Resolve high level issues for complex investigations, CAPAs, change requests, and engineering projects. Interacts with MSAT as LSM liaison.
Lead PHAs and EH&S reviews.
Develop process (and other) training materials and deliver training to Operations personnel.
Administer, document and maintain the Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Quality Systems tools, as well as direct actions.
Duties:
Assist in Process / Technology Transfers.
Assist with manufacturing process start-up.
Innovate Process Optimization and Capital improvements.
Ensure Regulatory Compliance.
May serve as the sites Preventative Controls Qualified Individual (PCQI) and/or Sanitation Supervisor for products being manufactured under 21 CFR 117 "Current GMP, Hazard Analysis, and Risk Based Preventive Controls for Human Food.
Perform other duties as required.
Supervision:
This position does not have supervisory responsibilities.
Keys to Success:
Education
Bachelor's Degree in Chemical Engineering, Chemistry, or related field.
Experience:
5+ yrs. experience in the pharmaceutical industry or related preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:
Excellent oral
Written and presentation/communication skills
Ability to interact effectively with all levels of employees
Ability to multi-task
Ability to work under tight deadlines.
Physical Requirements:
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk, hear or smell.
The employee is occasionally required to walk and stoop, kneel, or crouch. The employee must also occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this job include close vision, depth perception and ability to adjust focus.
Work Environment:
While performing the duties of this job, the employee is occasionally exposed to various types of chemical substances, carcinogens, corrosives, irritants, toxins, teratogens, mutagens, lethals (SDS information for review on an ongoing basis).
Safety and security procedures:
Determine appropriate action beyond guidelines
Report potentially unsafe conditions
Conduct compliance monitoring, investigations and training within area of responsibility
Excellent Benefits Package
Review our company's Total Rewards
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 6%
Tuition Reimbursement - eligible after 90 days
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $42 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies, or growing efficiency in their laboratories, we are here to support them. Our team of more than 100,000+ colleagues delivers an outstanding combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Fisher Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
For more information, please visit www.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
