Validation Specialist

We are seeking a highly skilled Validation Specialist to join our team at PCI Pharma Services. As a key member of our Quality Assurance department, you will play a critical role in ensuring the qualified state of all cGMP facilities, utilities, manufacturing, packaging, and analytical equipment.

1. Validation Approach: Participate in Risk Assessments to determine the validation approach for Facilities, Utilities, and Equipment, ensuring those with a GxP impact are appropriately qualified.
2. Documentation Compliance: Ensure documentation utilized for Facilities, Utilities, and Equipment Qualification has been generated in compliance with Statutory, Regulatory, Client, and Company expectations.
3. Project Collaboration: Work closely with Project Management Teams in Pharmaceutical Development, Technical Affairs, Operations, Supply Chain, and Clients to ensure projects are progressed in a timely manner.
4. Qualification Studies: Support the execution of Qualification studies, ensuring Standard Operating Procedures (SOPs) and Work Instructions (WIs) associated with the Qualification study are available and adequate for their intended use.
5. Equipment Calibration: Ensure all equipment used during a Qualification study is appropriately calibrated to a recognizable international/national standard.
6. Deviation Management: Document and manage any deviation to the acceptance criteria associated with a qualification study, and agree on an action plan as required.
7. Reporting and Conclusion: Report all key findings, concluding whether the Qualification study has been successful and whether the system is fit for routine GxP use.
8. Subject Matter Expertise: Be a Subject Matter Expert in one Validation discipline, and represent that expertise at client-facing meetings and audits.
9. Continuous Improvement: Periodically review Standard Operating Procedures (SOPs), Work Instructions (WIs), Templates, and Forms to standardize and optimize the Qualification approach while maintaining Regulatory compliance.

1. Manufacturing Experience: Experience in Manufacture and Packaging of Pharmaceuticals or Medical Devices, ideally Contract Pharmaceutical manufacturing of Oral Solid Dose, Oral Liquid Dose, Topical Ointments, and Creams.
2. Validation Expertise: Extensive working experience of Validation Disciplines, preferably Facilities, Utilities, and Equipment Qualification.
3. Regulatory Knowledge: Working knowledge of Good Manufacturing Practices, Eudralex Volume 4 specifically Annex 15 and ICH, particularly ICH Q9.
4. Technical Skills: Proficient user of software packages including MS Excel, Word, PowerPoint, and Visio, together with a high level of computer literacy.
5. Data Analysis: Able to statistically analyze data to determine process capability.
6. Communication Skills: Be a strong team player with open communication style, able to direct others and deliver clear instruction, including internal personnel, suppliers, and contractors.
7. Project Management: Proficient in the use of MS Project and Statistical Software.
8. People Management: People management experience (desirable).
9. Education: Educated to BTEC HND or degree level in a Technical, Engineering, or Science subject or a minimum of five years previous experience working in a similar technical role.
10. Communication: Face-to-face communication.
11. Listening Skills: Good listening skills.
12. Attention to Detail: Attention to detail.

We offer a comprehensive benefits package designed to support your well-being and enhance your overall quality of life. Our benefits include:

1. Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
2. Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.
3. Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.
4. Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.
5. Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you
6. Staff Engagement: We value your dedication with recognition schemes and long-service awards.
7. Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.
8. On-Site Subsidized Canteen.
9. Cycle to Work Scheme.
10. Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.