Production Specialist

Thermo Fisher ScientificGreenville, NC
Onsite

About The Position

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 through innovative solutions for some of the world’s toughest challenges. Discover Impactful Work: We are seeking a detail-oriented Production Specialist to support process excellence and continuous improvement initiatives within our GMP pharmaceutical manufacturing operations. In this role, you will focus heavily on technical writing activities, including the creation, review, revision, and maintenance of Standard Operating Procedures (SOPs), manufacturing documentation, and process-related procedures. You will partner with cross-functional teams to improve operational efficiency, strengthen quality systems, and ensure compliance with GMP standards. This position is ideal for someone with strong pharmaceutical manufacturing experience who is passionate about process optimization, documentation accuracy, and driving quality improvements in a fast-paced production environment. A Day in the Life: Create, revise, review, and maintain SOPs, work instructions, and manufacturing documentation related to GMP pharmaceutical production processes and equipment. Partner with Manufacturing, Quality, Engineering, and Project Management teams to support process improvements and operational excellence initiatives. Conduct root cause investigations and support corrective and preventive action (CAPA) activities related to manufacturing processes and quality events. Evaluate current manufacturing procedures and workflows to identify opportunities for improved efficiency, compliance, and performance. Assist with implementation of new or revised processes, including training production personnel across multiple shifts as needed. Support continuous improvement efforts through lean manufacturing and Practical Process Improvement (PPI) methodologies. Participate in project teams and cross-functional meetings to ensure alignment on production and quality goals. Maintain accurate documentation practices while ensuring compliance with GMP, SOP, and safety requirements. Develop and maintain a strong understanding of pharmaceutical manufacturing processes, production equipment, and operational procedures.

Requirements

  • Minimum 4 years of experience in pharmaceutical manufacturing, GMP operations, quality systems, or related production environments.
  • Experience with technical writing, including SOP creation, revision, and document control processes.
  • Strong understanding of Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and pharmaceutical manufacturing processes.
  • Demonstrated technical writing and documentation management skills.
  • Strong problem-solving and root cause analysis capabilities.
  • Excellent organizational skills and attention to detail.
  • Ability to work independently and collaboratively within cross-functional teams.
  • Strong written and verbal communication skills.
  • Proficiency with computer systems and Microsoft Office applications.
  • Ability to wear required Personal Protective Equipment (PPE) and lift up to 50 lbs as needed.

Nice To Haves

  • Additional technical training, certifications, or relevant coursework in manufacturing, pharmaceutical operations, or quality systems preferred.
  • Experience supporting continuous improvement or lean manufacturing initiatives preferred.

Responsibilities

  • Create, revise, review, and maintain SOPs, work instructions, and manufacturing documentation related to GMP pharmaceutical production processes and equipment.
  • Partner with Manufacturing, Quality, Engineering, and Project Management teams to support process improvements and operational excellence initiatives.
  • Conduct root cause investigations and support corrective and preventive action (CAPA) activities related to manufacturing processes and quality events.
  • Evaluate current manufacturing procedures and workflows to identify opportunities for improved efficiency, compliance, and performance.
  • Assist with implementation of new or revised processes, including training production personnel across multiple shifts as needed.
  • Support continuous improvement efforts through lean manufacturing and Practical Process Improvement (PPI) methodologies.
  • Participate in project teams and cross-functional meetings to ensure alignment on production and quality goals.
  • Maintain accurate documentation practices while ensuring compliance with GMP, SOP, and safety requirements.
  • Develop and maintain a strong understanding of pharmaceutical manufacturing processes, production equipment, and operational procedures.

Benefits

  • Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 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 complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
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