Senior Manufacturing Process Engineer Jobs in Raleigh, NC

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The Senior Manufacturing Technician (Compound/Fill/Finish) is accountable for results in a fast-paced environment and assists with the manufacturing of sterile injectable products in vial and syringe configurations for clinical/commercial distribution. The Senior Manufacturing Technician is a key role responsible for overseeing and executing advanced production tasks involving  compound, fill and finish processes for sterile injectable pharmaceutical products executed via aseptic isolator technology. This position entails a high level of technical expertise in aseptic processes requiring single-use components, leadership in troubleshooting, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP).

The Senior Manufacturing Technician 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). The Senior Manufacturing Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning.

The Senior Manufacturing Technician demonstrates proficiency in all department procedures, trains and coaches other technicians, and provides work instruction and oversees daily work assignments in the absence of the supervisor as needed. The Senior Manufacturing Technician interacts with customers as needed.

• 100% on-site position.

• Day Shift: 12-Hour Rotating (2-2-3), 7:00am - 7:00pm.

• Leads and performs complex manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection.
• Serves as a subject matter expert (SME) on compounding/filling processes and equipment, providing guidance and training to other manufacturing employees.
• Monitors production processes to ensure adherence to SOPs, batch records, and quality standards, making real-time adjustments to maintain product quality.
• Troubleshoots and resolves complex equipment and process issues, minimizing downtime and ensuring efficient production flow.
• Conducts in-process and end-of-process sampling/quality checks, ensuring all manufactured products meet rigorous standards.
• Collaborates with cross-functional teams (e.g., Manufacturing Specialists, Technical Services, Quality Assurance, Engineering, etc.) on continuous improvement initiatives to enhance product quality, safety, and efficiency.
• Assists with the validation and qualification of new equipment and processes, ensuring seamless integration into the production workflow.
• Maintains accurate and detailed production documentation. Documentation is completed with minimum errors and recommendations are escalated to drive document revisions to reduce errors.
• 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.
• Demonstrates technical ability in all manufacturing technologies and utilizes technologies per SOPs and cGMPs. Executes SOP revision as needed to implement process improvements.
• Legibly documents activities in real time on controlled documentation per SOPs and cGMPs.
• Performs in-process sampling, weight checks, and component counting and basic math calculations.
• Performs in-process inspection and finished product visual inspection.
• Performs cleaning of rooms, tools and equipment before and after use.
• Assists with other manufacturing areas as required.
• Performs activities right first time in areas of material handling/dispensing, compounding, and filling.
• Follows general instructions on routine work and detailed instructions on new projects or assignments.
• Follows all Safety requirements and leads by example a safety-first culture.

• Works occasional hours outside of scheduled shift based on business needs, which may include weekend work.

• Other duties as assigned.

• High school diploma or GED required. Associate or Bachelor’s degree preferred.
• 5+ years of GMP experience in pharmaceutical manufacturing, with a strong background in sterile/aseptic manufacturing or Drug Substance manufacturing.

• Responsible for providing oversight and supervision of all tasks being performed. Capable of executing tasks with minimum oversight while giving guidance to team to ensure manufacturing success.
• Excellent verbal and written communication skills, works collaboratively in a team environment and stands in for Lead during shift exchange.
• Proven ability to operate, troubleshoot, and maintain complex manufacturing equipment.
• Demonstrated leadership skills, with experience training and mentoring team members.
• Strong analytical and problem-solving skills with a focus on detail and accuracy.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Applies job skills, company policies, and SOPs to complete a variety of tasks.
• Strong detail orientation and organizational skills required.
• Strong problem-solving and basic trouble-shooting ability required.
• Ability to train others effectively.
• Ability to perform basic math calculations.
• Ability to read and comprehend detailed written instructions and apply instructions during execution is required.
• Ability to move materials throughout the facility using appropriate methods and equipment required.
• Proficiency in basic computing skills required.
• Ability to use the appropriate PPE based on product (i.e. PAPR, Supplied Air Respirator).
• Knowledge in these manufacturing technologies:
  • Equipment and component preparation and sterilization (i.e., autoclaving)
  • Compounding
  • Vial Washing / Depyrogenation
  • Aseptic Filling / Stoppering / Capping
  • Lyophilization
  • Visual Inspection
  • Facility Cleaning/Sanitation
  • Documentation Review (Batch Record, Logbooks, etc.)

• Up to 5% domestic travel expected.

The physical demands and work environment characteristics described here 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. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee 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 by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The employee must have 20/20 vision (with or without corrective lenses) and must possess the ability to pass a color-blind test.

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 the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. The use of tight-fitting respirators limits facial hair for proper protection. Based on product, the use of PAPR or supplied air respirator may be required. Regulations may require employees to participate in routine medical surveillance. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle such as a forklift.