Senior Technical Specialist - Manufacturing Validation

Almac Group; Leicester; On-site; GBP 65,000 - 80,000; Full time

Job summary

Almac Pharma Services in Leicestershire, United Kingdom, is seeking a Senior Technical Specialist to drive product/process validation, PPQ campaigns and CPV for commercial products. You will lead qualification activities across equipment and facilities, maintain validated state, and collaborate with QA, Engineering and Production to ensure compliant, inspection-ready operations.

Applicants should have proven GMP PV experience, strong technical writing, and a track record of leading

Qualifications

• Proven process validation experience in GMP drug products with PPQ leadership.
• Experience with FDA PV, EU Annex 15, ICH Q8/Q9/Q10 is required.
• Strong technical writing for protocols and reports.
• Ability to lead cross-functional validation workstreams.
• Degree in Life Science or Engineering is required.

Responsibilities

• Lead PPQ: author/approve protocols, sampling plans, acceptance criteria, and PPQ reports.
• Lead equipment and facility qualification lifecycle per DQ-IQ-OQ-PQ.
• Prepare URS, functional specs, TRs, IQ/OQ, and summary reports for validation.
• Manage deviation/CAPA and validation impact assessments for changes.
• Interface with audits and represent validation in inspections.

Skills

PPQ leadership

CPV expertise

data integrity

Quality systems

cross-functional collaboration

Education

Life Science or Engineering degree

Tools

Minitab

JMP

TrackWise (eQMS)

Job description

An opportunity has become available to join our Manufacturing Support department in the role of Senior Technical Specialist. In this role your primary job purpose is product/process validation, and you will own PPQ campaigns and enable robust CPV for commercial products at our Charnwood site, ensuring processes remain in a validated state and inspection-ready at all times. You'll partner closely with Manufacturing Operations and the wider Technical Operations Group to turn science and data into compliant, reliable supply. You may also lead equipment and facility qualification for GMP-relevant equipment using DQ-IQ-OQ, ensuring systems are designed, installed, operated and perform, and continue to perform as intended.

What you'll do

• Lead PPQ: author/approve protocols, define sampling plans and acceptance criteria, oversee execution, analyse data, and issue PPQ summary reports for timely release
• Lead or participate in equipment and facility qualification: Deliver qualification lifecycle for GMP-relevant equipment using DQ-IQ-OQ-PQ and maintain equipment in validated state through periodic review and scheduled requalification, aligned to site procedures and Annex 15 expectation and including data integrity (ALCOA, computerised system lifecycle principles)
• With echnical Operations and Quality, generate URS, generate, review and approve functional/technical specifications, Quality Risk Assessment, Traceability Matrix, IQ/OQ protocols and summary reports.
• Investigations & change: lead deviation/CAPA, conduct Quality Risk Management, author change requests, and manage validation impact assessments for changes
• Interface with audits: represent equipment and process validation in customer/regulatory inspections and defend strategy, execution and reports
• Collaborate across functions: work with QA, Analytical/QC, Engineering and Production to execute qualifications or PPQs to plan.
• Broader validation: coordinate equipment/cleaning validation to ensure end-to-end compliance and data integrity across the lifecycle.

Experience:

Proven process validation experience in GMP drug product (OSD preferred), including PPQ leadership and CPV

Regulatory knowledge:

Practical application of FDA 2011 PV, EU GMP Annex 15, and ICH Q8/Q9/Q10.

Statistics & tools:

Competence with SPC/trending (e.g., Minitab/JMP) and strong technical writing for protocols and reports.

Quality systems:

Experience with eQMS (e.g., TrackWise,) 21 CFR Part 11/Anne 11 and ALCOA+ principles.

Collaboration:

Ability to work in and lead cross-functional teams (e.g. Production, Formulation Development, Engineering), manage multiple PPQ workstreams, and meet committed timelines to plan.

Degree:

in Life Science or Engineering, or equivalent

For over 50 years Almac Pharma Services has manufactured and packed oral solid dose medicines-tablets, capsules and powders-supplying patients worldwide.

A fantastic salary and benefits package is available, including annual bonuses for all, generous holiday allowance, healthcare reimbursement scheme, and a rewarding role where the work you do will ultimately be contributing to the advancement of human health.