Process Specialist (Maternity cover)

SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies. For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes. Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m.

With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries. Our Purpose is supported by our 4 key values:

• We make patients our priority
• We act with integrity and accountability
• We work together as one team
• We look for better ways forward

By expanding our reach through selective acquisitions and entering new markets, we’re not just supplying medicine; we’re improving the standard of care for more patients around the world.

Broad Overview

Responsible for providing technical expertise to the Production team. Responsible for providing appropriate training to the manufacturing team to ensure level of process and product understanding is contained. As Process Specialist, your responsibilities will include:

• Provide technical input into validation activities for the Production team – write, review, approve and execute studies as required.
• Perform administrative tasks and provide rapid issue resolution for all electronic manufacturing systems, including EAMS, MES and computerized processing equipment controlling systems.
• Work alongside internal & external functions to transfer new equipment and techniques effectively & efficiently to production scale.
• Active participant for site Operational Excellence initiatives.
• Foster and encourage Continuous Improvement within the Production department.
• Lead process improvement initiatives and activities to influence change.
• Maintain and update knowledge and expertise of current developments, standards and operating practices within the biotechnology and pharmaceutical industries.
• Input into the Regulatory strategy and author the relevant sections of Regulatory dossiers to support both Changes & Deviations.
• Ensure practical training modules are in place so that new starters within the teams are provided with sufficient background understanding and knowledge before entering into their roles.
• Provide training to new starters and robust re‑training modules to maintain high compliance within the teams.
• Provide subject matter expert input to Regulatory, internal and external audits.
• Cover operator absence within the facility as required.
• Carry out other reasonable tasks as required by the Line Manager.
• Ensure that all interactions and engagements are carried out in accordance with Company values.

The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

To be successful in this role, you should demonstrate:

• Educated to degree level in an appropriate scientific discipline.
• Significant experience in a biopharmaceutical or closely related industry.
• Excellent understanding of cGMP legislation.
• Strong technical background with an excellent working knowledge of GMP, Quality and Regulatory understanding.
• Good listening/communication skills and ability to carry out investigations by gathering information from others.
• Methodical, organised and show attention to detail.
• Strong organisational skills with an ability to plan ahead.
• Strong technical writing skills.
• Ability to communicate effectively at all levels.
• Ability to work under pressure and coordinate several activities concurrently.