Formulation Technician Ii

Working in Lyophilization and Control Room
Operate lyophilization equipment used to manufacture sterile products. Keep accurate and up-to-date batch records and data sheets on batches in-process. Monitor environmental conditions to ensure products are filled within specified parameters to meet sterility standards and escalate any issues to proper personnel for troubleshooting. Perform preventative maintenance tasks to ensure that equipment and areas meet specifications. Recognize equipment and product problems, notify supervisor and/or troubleshoot errors in order to achieve optimum production levels. Perform other duties as assigned by supervision. A strong mechanical aptitude is beneficial in this position. Typical hours for this role is 4 on 4 off from 6:00p – 6:00a.

EDUCATION:

• High school diploma or equivalency is minimally required. Technical degree preferred.

EXPERIENCE:

• 2 years of regulated manufacturing (Pharmaceutical preferred), mechanical or similar experience.

Equivalency:

• Equivalent combinations of education, training, and relevant work experience may be considered.

KNOWLEDGE, SKILLS, ABILITIES:

• General mechanical, electrical/electronic, pneumatic, and hydraulic knowledge of pharmaceutical industry equipment.
• Effective verbal and written communication skills.
• Basic computer skills.
• Strong interpersonal skills.
• Ability to work independently.
• Flexibility with departmental work schedules, including overtime and all shift operations.
• Ability to achieve and maintain qualifications to work in a cleanroom environment.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium weights of 25-50 pounds; occasionally pushing and pulling 50-100+ pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Ability to climb stairs and ladders. Full range of motion in upper and lower extremities.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues 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 and Patheon. 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.

Ensure operations are performed in a safe and responsible manner striving to create an injury-free and incident-free workplace.

Ensure pharmaceutical products are produced in accordance to Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs) and other batch related activities.

• Verify and document production activities in batch records, logbooks, etc.
• Assist in troubleshooting operational and production problems in order to identify appropriate corrective actions.
• Perform visual inspection and turnaround activities for the freeze drying equipment. Prepare equipment and components for operations.
• Assist in the commissioning of new equipment and production areas. Assist in initial and subsequent validation of equipment and processes.
• Maintain/clean classified environments/areas.
• Communicate and work to resolve any production, quality or safety issues.
• Comply with all job-related safety, cGMP, and other department procedural requirements.
• Participate in the On the Job (OJT) training program, area safety initiatives, and area initiatives.
• Train new employees.
• Perform other duties as assigned.