GMP Process Engineer: Lead New Process Introductions

NextPharma; Livingston; Hybrid; GBP 42,000 - 62,000; Full time

Job summary

NextPharma is seeking a Process Engineer to facilitate introduction of new processes and equipment within the production department. You will lead qualification of equipment, train staff, and provide technical support to development and production teams to meet schedules while maintaining GMP standards.

Role requires an engineering/scientific background with pharma experience, strong communication skills, and ability to work across levels.

Qualifications

• Engineering and/or scientific background with relevant pharmaceutical/chemistry/engineering experience (or BSc equivalent).
• Experience from similar positions in the industry.
• Excellent oral and written communications skills.
• Authoring and executing equipment qualification.
• Able to communicate effectively with people at all levels within the Company.

Responsibilities

• Participating in all aspects of product manufacture.
• Leading introduction of new processes and equipment to facilitate clinical and commercial manufacture.
• Leading qualification of new and existing equipment.
• Training of production staff in new processes and procedures.
• Providing technical assistance to development and production staff to ensure timely completion of scheduled manufactures.
• Identifying, assessing, and implementing process improvements across functional area.
• Maintaining GMP compliance in accordance with MHRA, FDA, customer, and corporate expectations.
• Drafting SOPs for new equipment to facilitate training and standardise equipment cleaning, set-up and operation.
• Leading departmental change controls, quality event investigations, and CAPA.
• Trending process KPI’s and monitoring production performance to measure effectiveness of process improvements.
• Ensure all SOPs accurately reflect best practice.

Skills

Statistical analysis

Communication skills

Equipment qualification

Cross-level communication

Education

BSc or equivalent in Chemical Engineering, Pharmaceutical Sciences, or Mechanical Engineering

Tools

MS Office

Excel

Word

Project

Job description

NextPharma is seeking a Process Engineer to facilitate introduction of new processes and equipment within the production department. You will lead qualification of equipment, train staff, and provide technical support to development and production teams to meet schedules while maintaining GMP standards.

Role requires an engineering/scientific background with pharma experience, strong communication skills, and ability to work across levels.