Process Engineer

NextPharma; Livingston; On-site; GBP 42,000 - 65,000; Full time

Benefits offered by this job

Free on site parking

Medical Cover

Life cover

EAP

Pension

Job summary

NextPharma in the United Kingdom seeks a Process Engineer to facilitate introduction of new processes and equipment within the production department. You will lead qualification activities, train staff, and provide technical support to development and production teams to ensure timely manufacture of clinical and commercial batches.

The role requires a strong background in engineering/science within the pharmaceutical sector, experience with GMP, and excellent communication skills to collaborate

Qualifications

• Engineering and/or scientific background with 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
• Management skills are desirable merits
• Excellent oral and written communications skills
• Authoring and executing equipment qualification
• Able to communicate effectively with people at all levels within the Company

Responsibilities

• 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

Skills

Engineering background

Industry experience

Statistical analysis

Communication skills

Equipment qualification

Management skills

Team player

Clear written/verbal communication

Education

Chemical/Pharmaceutical/Mechanical Engineering degree

Tools

MS Excel

MS Word

MS Project

MS Office Suite

Job description

• Management skills are desirable merits

We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,250 employees in Germany, France, Finland, Norway and the UK. 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
• Management skills are desirable merits
• Excellent oral and written communications skills
• Authoring and executing equipment qualification
• Able to communicate effectively with people at all levels within the Company

Desired

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

Lean Six Sigma green belt or above

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

• Free on site parking
• Medical Cover
• Life cover
• EAP
• Pension