Manufacturing Technician II - Oral Solid Dosage - 1st Shift

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise, and a proven regulatory track record.

About the Role

The Manufacturing Technician II Oral Solid Dosage (OSD) is accountable for results in a fast-paced environment and assists with the manufacturing of oral solid dose products for commercial distribution. This role performs the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs).

Schedule

• 100% on-site position
• 1st Shift: Monday - Friday, 8:00am - 4:30pm
• Occasional hours outside of scheduled shift based on business needs, which may include weekend work

Responsibilities

• Follows applicable SOPs and cGMPs to perform assigned duties and tasks
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements
• Performs applicable manufacturing techniques and technologies per SOPs and cGMPs
• Performs manufacturing technologies and operation of manufacturing and material handling equipment
• Documents activities in real time on controlled documentation and legibly, per SOPs and cGMPs
• Performs in-process testing, weight checks, component counting, and basic math calculations
• Performs cleaning of rooms, tools, and equipment
• Assists with other manufacturing areas as required
• Performs activities right first time in areas of Solid Oral Dosage: Microencapsulation, Blending, and Bulk Packaging
• Applies job skills, company policies, and SOPs to complete a variety of tasks
• Follows general instructions on routine work, detailed instructions on new projects or assignments
• Follows all Safety requirements and leads by example a safety-first culture
• Maintains accurate and detailed production documentation in compliance with GMP, FDA regulations, and Alcami's internal policies
• Other duties as assigned

Requirements

• High school diploma or GED required; Associate’s degree preferred
• 3+ years of relevant experience preferred (Drug Substance manufacturing experience will be considered)
• Prior manufacturing work environment required
• cGMP or prior work experience in a regulated environment required
• Prior pharmaceutical or CDMO experience required
• Candidates with life sciences or engineering degrees will be considered without manufacturing experience

Skills

• Good verbal and written communication and documentation skills
• Detail orientation and organizational skills
• Problem-solving and basic trouble-shooting ability
• Ability to perform basic math calculations
• Ability to read and comprehend detailed written instructions
• Ability to move materials throughout the facility using appropriate methods and equipment
• Proficiency in basic computing skills
• Ability to use the appropriate PPE based on product (i.e., PAPR, Supplied Air Respirator)

Physical Demands and Work Environment

The physical demands and work environment described are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and smell
• Frequently required to walk; climb or balance; and stoop, kneel, crouch, or crawl
• Occasionally required to sit
• Must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, occasionally lift and/or move up to 75 pounds, and occasionally lift and/or move over 75 pounds with assistance
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus
• Frequently exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals
• Occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock; and vibration
• Noise level in the work environment is usually moderate
• Required to wear appropriate personal protective equipment (PPE) such as safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, and various types of gloves
• Use of tight-fitting respirators limits facial hair for proper protection
• May require routine medical surveillance
• Other tasks involving elevated work may require the use of a body harness and lanyard
• May be required to operate an industrial vehicle