Please Note: The application deadline for this job has now passed.
Job Introduction
We are looking for:
A Process Technician compliant in manual & DCS control and operation of all site manufacturing process trains for the production of Active Pharmaceutical Ingredients (APIs). You will be performing supporting activities that facilitate the compliant operation of the site manufacturing process trains in accordance with the site production plan to deliver API manufacture on time, in full.
A Process Technician compliant in manual & DCS control and operation of all site manufacturing process trains for the production of Active Pharmaceutical Ingredients (APIs). You will be performing supporting activities that facilitate the compliant operation of the site manufacturing process trains in accordance with the site production plan to deliver API manufacture on time, in full.
At Pharmaron we offer:
- Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
- Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
- A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!
Key roles and responsibilities:
Environment, Health and Safety
• Strictly follow all site EHS policies and procedures.
• Perform all tasks in strict accordance with risk assessments, Standard Operating Procedures (SOPs), and Batch Manufacturing Instructions.
• Report EHS Adverse Events – such as near misses, safety concerns, incidents and accidents via the site EHS Adverse Event reporting application.
• Take responsibility for your personal safety as well as that of your colleagues.
• Operate within the limits of the site’s Environmental Permit.
• Undertake emergency response tasks as required which may include loss of containment, supporting emergency services, and rescue operations involving confined space entry and working at height.
• Act as a production representative for process risk assessments, including HAZOP, LOPA, and Safety Critical Task Analysis.
• Manage Safe Systems of Work in process areas by performing task-based risk assessments, issuing general safe working permits, and supporting high hazard permits.
Quality
• Carry out all process operations in accordance with full cGMP requirements and any other relevant quality standards.
• Complete process operations documentation in accordance with established cGMP standards.
• Report any quality deviations using the site’s quality deviation reporting application.
• Maintain all process facilities to ensure they are always audit-ready.
Operations
• On plant, control and operation of all site process trains as per the site production plan, including:
o Configuration, cleaning, and commissioning of process trains.
o Manufacture of APIs while strictly adhering to quality and safety critical parameters, as well as controlled operating procedures and batch instructions.
o Maintaining control of process trains via DCS and manual operations. Maintain control of process trains using DCS and manual operations.
o Manage process waste streams effectively.
o Trade effluent treatment and ensure proper discharge procedures are followed.
o Conduct tanker operations in compliance with safety standards.
• Develop and maintain operational procedures, including authoring batch records, cleaning SOPs, and other plant/process-related procedures.
• Carry out troubleshooting / diagnostic activities in response to process deviations, ensuring that any issues are addressed or escalated to the Line Manager or appropriate personnel.
• Perform investigations and conduct Root Cause Analysis (RCA) for quality deviations, EHS adverse events, and process upsets.
• Make informed decisions regarding recovery from process upsets, following cause and effect matrices and relevant technical guidance.
• Serve as the Subject Matter Expert (SME) for process train operability.
• Perform laboratory analyses as required.
• Conduct process plant first-line maintenance activities.
• Provide training and mentoring for all operational requirements.
• Take on any other reasonable duties as assigned by the Line Manager
Agile Approach: The role requires the ability to physically operate all site process trains and transition between them according to campaign needs, performing both automated and manual tasks.
Flexible Shift Approach: A flexible approach to shift work is necessary based on operational requirements. The working pattern will adjust according to plant occupancy and processing demands.
Technical Capability: Strong technical capabilities are essential for effective decision-making on all processing aspects.
QUALIFICATION
ESSENTIAL
• GCSE level C or above in English, Maths, Chemistry or physics
DESIRABLE
• Degree in Chemical Processing, Pharmaceutical Science or related discipline
• City and Guild level 1 or 2 in Process Technology Chemical Processes or equivalent
• IOSH Working or Managing Safely
EXPERIENCE
ESSENTIAL
• Minimum of 3 years’ experience in a technical manufacturing environment – chemical, pharmaceutical or equivalent
• Experience of working in a high hazard environment
• Experience of following batch manufacturing instructions / procedures and adherence to strict control parameters
DESIRABLE
• Experience of working within a cGMP / highly regulated environment
• Experience of training or mentoring others under a competency management framework
• Experience of authoring standard operating procedures
• Experience of contributing to hazard identification and operational risk assessment
• Experience of performing emergency response tasks such as response to loss of containment
KNOWLEDGE & SKILLS
ESSENTIAL
• Knowledge of risk management and Safe Systems of Work
• Ability to make data-based decisions
• Ability to work effectively under minimal supervision
• Appreciation of quality systems and cGMP
• Strong written and verbal communication skills
DESIRABLE
• Ability to recognise atypical situations and implement appropriate recovery actions
• Problem solving and root cause analysis skills
• Knowledge and understanding of process safety, reaction hazards and potential consequences
ATTRIBUTES (QUALITIES/BEHAVIOUR)
ESSENTIAL
• Demonstrates a strong sense of ownership and accountability
• Innovation & Change: Challenge the status quo and champion new initiatives; encourage others to support change opportunities
• Integrity: Show consistency between words and actions
• Team Player: Work effectively and cooperatively with others; establish and maintain good working relationships
• Methodical with a keen eye for detail
• Continuously Learn: Demonstrate and encourage new knowledge, experiences, and challenges; demonstrate an awareness of own strengths and development needs
• Coach Others: Provide constructive & actionable feedback to others; provide a positive model to help others develop
Our Company:
“We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.
We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.
Our Cramlington site, just north of Newcastle, has an established history of cGMP
manufacturing services for an array of Active Pharmaceutical Ingredients (API), ranging from pilot scale to commercial metric ton scale. The Cramlington Site has more than 100 cubic meters reactor commercial capacity and has been inspected and approved by the MHRA, FDA and other regulatory authorities. The site operates from small scale in the laboratory through to large manufacturing scale. It also offers chemistry and analytical development service.
- We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
- We offer state of the art working environment on site.
- We offer the opportunity for growth and development and will support funding for relevant training and development programmes.
Why Should You Apply?
- This is an opportunity for you as a skilled professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
- Build and shape your career in an environment that sets and commits to the highest standards.
- To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.
Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 21,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.