Process Engineer - MSAT, GMP, Tech Transfer

About the role

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. The Process Engineer drives results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing.

100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
• Writes Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc.
• Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
• Author manufacturing investigations and complete CAPA assignments.
• Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.
• Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.
• Interacts with clients during routinely scheduled project meetings.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Requirements

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field required.
• Minimum 2 years of experience in technical support and technical transfer in a sterile pharmaceutical manufacturing environment.

Skills

• Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization, and time management skills.
• Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
• Proficiency with Microsoft Office (Word, Excel, Outlook).
• Ability to interact with internal stakeholders and external customers.
• Working knowledge of EU regulations is preferred.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met 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.

• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell.
• The employee is frequently required to sit.
• The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl.
• The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals.
• The employee is occasionally exposed to wet and/or humid conditions; high, precarious places, risk of electrical shock, and vibration.
• The noise level in the work environment is usually moderate.
• The employee will be required to wear appropriate personal protective equipment for specific job duties, which may include safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
• Other tasks involving elevated work may require the use of a body harness and lanyard.
• The employee may be required to operate an industrial vehicle.