Process Engineer

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

We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,300 employees in Germany, France, Finland, UK and Norway. For us, the next step is always the one that matters most. Our fast pace drives us forward, fills our working environment with life and spurs our growth. Our winning formula for shared success: room for passion. Because we know that passion is the best medicine when it comes to excellent service around the world. Welcome to NextPharma.

Job Purpose:

Facilitate introduction of new processes and equipment within the production department.

Key responsibilities and accountabilities:

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
• Ensuring that clinical and commercial batches are manufactured in accordance with agreed quality standards
• Maintaining GMP compliance in accordance with MHRA, FDA, customer, and corporate expectations
• Liaising with Facilities and Quality groups to maintain equipment calibration
• 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

Person Profile: Process Engineer

Personality:

Results oriented with a positive outlook and clear focus on high quality output; Reliable, tolerant and dependable; Comfortable dealing with people at all levels in the organisation; Comfortable working with a global customer base; Enjoys working in a fast, stimulating environment; Goal-oriented; Willing to learn from others; Good written and verbal communication skills; Team player, but one who is equally comfortable working independently; Attention to detail.

Personal Situation

Flexible and able to work extended hours when required.

Specific Job Skills:

Required:

• . Engineering and/or scientific background with relevant pharmaceutical/chemistry/Engineering experience (or BSc equivalent education)
• . Experience from similar positions in the industry
• . Strong understanding of statistical analysis
• . Flexible, structured and goal orientated team player
• . Excellent oral and written communications skills
• . Authoring and executing equipment qualification
• . Able to communicate effectively with people at all levels within the Company

Educated to degree or equivalent standard in Chemical Engineering, Pharmaceutical Sciences, or Mechanical Engineering

Experience of working in a GMP environment

Computer skills: Must be adept in the use of MS Office, particularly Excel, Word and Project
e-mail and internet

Literacy and Numeracy: Must be competent in generating documents both for internal use and for customers/clients. Must be numerate.

Business Presentation Skills: Must be an excellent face-to-face and remote communicator.

Please note – only applicants with a permanent Right to Work in the UK will be considered