Validation Specialist

Come and Save Lives with Us!

SERB Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases.  We have over 470 employees in 16 countries and a group revenue in excess of €350m.

Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

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       

Broad Overview 

This individual will work closely with our Hattiesburg, Mississippi site, and report into the Group Validation Manager (UK based) with a direct line to the Sr. Manager of Manufacturing Operations at the Hattiesburg site. 

To deliver all validation activities to support manufacturing at the Hattiesburg Mississippi site, ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities. An individual who will maintain adherence to the efficient delivery of the Site Validation Master Plan (SVMP) and Schedule.  

This individual will also have Validation responsibility over our Wales and Australia sites as required.

As a Validation Specialist, your responsibilities will include:  

• Responsible for the efficient and timely delivery of Validation activities with respect to qualification of new and existing facilities, utilities, products, processes, manufacturing, packaging and computerized systems  

• Responsible for the generation, approval or review of all validation documentation including but not limited to; Validation plans, Process validation documents, installation, operation and performance qualifications and reports.  

• Execution of validation testing for manufacturing equipment, utility systems equipment, processes, cleaning validation, product hold times, and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.  

• To follow all Standard Operating Procedures (SOP’s), Policies, Quality Records (QRs) and Batch Manufacturing Records (BMRs) and to participate in the generation, completion and review of such documentation when required, to agreed timelines.  

• The co-ordination of internal staff and external contractors during the scheduling and implementation of validation projects.  

• To document all EHS incidents and cGMP events to agreed timelines using the required business systems. Responsible for the generation and review of Validation EHS Risk Assessments.  

• To assist in the development and training of validation related policies and procedures of themselves and other personnel.  

• Responsible for ensuring that the SVMP qualification schedule for the site is maintained in compliance at all times.  

• Responsible for the scheduling of, and providing support where required for the coordination of equipment and system calibrations and / or service requirements for both internal and external service providers  

• The ability to communicate and deliver information to Senior Management and / or key Validation stakeholders as and when required.  

• Being the Validation lead for SERB at all Regulatory Inspections and contributing to any required validation responses from regulatory findings during site inspections.  

• Supporting and executing internal audits where required, taking responsibility for the closure of assigned actions in a timely manner.  

• Ensuring that critical changes are impact assessed and appropriate controls/actions are in place to secure on going manufacture.  

• Supporting System Owners in the generation and execution of validation activities across major projects  

• Continuously look to support continuous validation improvement activities.  

• Responsible for the generation of departmental CAPEX supporting projects through to completion.  

• Responsible for the generation of the Validation Quarterly Report.  

• When required reporting the departmental adherence to Site metrics (Validation, Quality, EHS).  

• Support other departmental activities as requested by department management or designate.  

• Ensure that all work is accomplished with quality and in accordance with SERB values.  

• Carry out other reasonable tasks as required by the Line Manager.  

• To participate in subsequent root cause investigations and perform corrective and preventative activities that may be assigned, on time.  

Principal Relationships  

1. Accountable to the Group Validation Manager.  

2. Internal – Liaise with all departments as necessary.  

3. External – Maintain external contacts e.g. suppliers, contract facilities and distributors, where appropriate.  

4. Travel to Hattiesburg for physical validation activities. Individual could also support Wales and other sites where required. 

Skills and Attributes  

1. Technical knowledge, high standards of attention to detail and the desire to see tasks through to completion  

2. Must be “hands-On” with a wide breadth of validation understanding to allow adaptability to the different types of validation including Cleaning validation, Sterilisation Validation, Temperature Mapping, Process Validation, Equipment Qualification, Computer Systems Validation and Data Integrity compliance.  

3. Ability to identify, organize and communicate complex technical problems with strong attention to detail and organizational skills.  

4. Excellent interpersonal skills being able to communicate effectively with a wide range of individuals and groups due to the changeable, team-oriented, project nature of the work  

5. Proven ability and desire to continuously improve, by seeking new approaches, generating ideas and demonstrating a determination to secure business advantage from such initiatives.  

6. Must be a completion driven individual, with the attitude to drive projects to completion in considerable detail  

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: 

• Degree in an appropriate scientific discipline or equivalent.  

• Strong technical background, gained from a highly regulated environment: API Manufacturing facility, medical devices, pharmaceutical, biotechnology or related industry.  

• Previous experience within a validation role essential. 3+ years preferred 

• Provide a sound understanding of the regulatory guidance for API manufacturing and medical devices, validation and qualification requirements of manufacturing equipment qualification, computer systems validation, utility systems, cleaning validation and process validation.  

• Excellent understanding and hands–on working knowledge of cGMP, quality and regulatory requirements for commercial material.  

• Demonstrated knowledge of cGMPs, MHRA, FDA regulations and current industry practices.  

• Experience of front line involvement with Regulatory Inspections.  

• Ability to travel to multiple sites for Validation activites as required. 

• US Citizen mandatory 

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.