Production Specialist

About the role

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.

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.

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed. Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.).

Requirements

• High school diploma or equivalent required.
• 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.
• Experience supporting continuous improvement or lean manufacturing initiatives preferred.

Knowledge, Skills, Abilities

• 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.

Physical Requirements

• Moderate physical exertion is required, including lifting medium-weight objects, bending, crouching, stretching, and reaching.
• Frequent operation of equipment, including keyboards, and prolonged periods of walking, sitting, or standing are necessary.
• Regular exposure to manufacturing environments that may include dust, fumes, or odors is expected.
• Use of Personal Protective Equipment (PPE) and adherence to safety procedures is required.