Manufacturing Process Specialist at Tandem Project Management Ltd. in County Louth, Ireland | Kablio

Role

Description

root cause

capa

commissioning

qualification

lean six

gmp documentation

Lead or support manufacturing investigations, root cause analysis, and CAPA development in collaboration with cross-functional teams.
Support equipment commissioning, qualification, and validation activities, including FAT, SAT, IQ and OQ.
Work in partnership with MS&T to provide technical leadership and knowledge sharing within the Drug Substance organisation.
Provide on-the-floor technical support during commercial manufacturing operations.
Contribute to continuous improvement initiatives to enhance compliance, quality, and manufacturing capability.
Support batch disposition activities by providing SME input for technical comment resolution.
Support process and quality improvements through the application of Lean Six Sigma and risk-based tools.
Provide technical support to Drug Substance manufacturing operations, including cell expansion, bioreactor, and downstream processes.
Coordinate and execute technical deliverables to support project execution and product launch.
Prepare, review, and update GMP documentation, including batch records, SOPs, and technical reports.

Requirements

bachelor's

equipment qualification

technical writing

cell culture

gmp

deviation mgmt

Bachelor’s degree in Engineering, Science, or a related technical discipline.
Hands-on experience with equipment qualification and manufacturing support activities.
Proven technical writing capability and attention to detail.
Experience supporting Drug Substance operations, including cell culture and downstream processing.
Knowledge of GMP requirements and regulatory guidelines, including Annex 1, desirable.
Minimum of 3 years’ experience in a GMP environment within biological, vaccine, or pharmaceutical manufacturing.
Experience in start-up or project-based manufacturing environments is advantageous.
Strong experience in deviation management, investigations, and data-driven root cause analysis.

Benefits

Information not given or found

Training + Development

Information not given or found

Interview process

Information not given or found

Visa Sponsorship

Information not given or found

Security clearance

Information not given or found

Company

Overview

Founded in the heart of Ireland, Tandem Project Management Ltd. has grown into a key player in delivering high-quality project management solutions across multiple industries.
The company has a proven track record of success in managing large-scale, complex projects, consistently delivering on time and within budget.
Specialising in sectors like industrial, commercial, residential, and transport, Tandem brings expertise to projects ranging from urban developments to large infrastructure projects.
Tandem Project Management Ltd. thrives in challenging environments, with a deep understanding of project intricacies and client requirements.
Their approach is rooted in collaboration, working closely with clients and stakeholders to ensure projects meet all expectations and deliver lasting value.
The firm is known for its hands-on, proactive management style, providing solutions at every stage of the project lifecycle.
With a focus on maintaining robust relationships, Tandem is dedicated to fostering trust and long-term partnerships with clients.

Culture + Values

2017

Continuous Professional Development

The company has been accredited by Engineers Ireland for CPD since 2017, demonstrating a commitment to ongoing professional development and standards.

Repeat Business

Client Loyalty Track Record

The company maintains a strong track record of repeat business, reflecting its ability to consistently deliver exceptional results and build lasting partnerships.

Safety and quality are at the heart of everything that we do.
Openness, transparency and collaboration.
Client‑centred, collaborative approach.
Tailored approach to meet client needs.
Driven by senior team who lead by example in professionalism and commitment.
Lean techniques and value management methods to ensure fit‑for‑purpose outcomes and best value for money.

Environment + Sustainability

42% Reduction

Commitment to GHG Emissions

Targeting a significant reduction in greenhouse gas emissions as part of a science-based approach.

Committed to 42% reduction in Greenhouse Gas emissions by 2030
Established Carbon Action Team to measure, monitor and report GHG emissions annually to the Carbon Disclosure Project
Initiatives include purchasing renewable energy, sourcing sustainably produced goods and services, monitoring and reducing waste
Reducing paper usage, switching to electric company vehicles, ensuring efficient office utilities, seasonally adjusting temperature controls

Inclusion & Diversity

Rating: 4.1/5

Equality, Diversity, and Inclusion

Based on Glassdoor reviews, the company has a strong rating for its commitment to Equality, Diversity, and Inclusion.

Rating: 3.8/5

Culture and Values

Glassdoor reviews highlight the company's overall Culture and Values, reflecting employee sentiment on workplace environment.

Glassdoor reports ‘collaboration, respect, training, teamwork, autonomous working’ as pros
Glassdoor reports ‘management are friendly and respectful’
No public gender-split or DEI quantitative stats published

Articles

Projects

Careers

Role

Description

root cause

capa

commissioning

qualification

lean six

gmp documentation

Lead or support manufacturing investigations, root cause analysis, and CAPA development in collaboration with cross-functional teams.
Support equipment commissioning, qualification, and validation activities, including FAT, SAT, IQ and OQ.
Work in partnership with MS&T to provide technical leadership and knowledge sharing within the Drug Substance organisation.
Provide on-the-floor technical support during commercial manufacturing operations.
Contribute to continuous improvement initiatives to enhance compliance, quality, and manufacturing capability.
Support batch disposition activities by providing SME input for technical comment resolution.
Support process and quality improvements through the application of Lean Six Sigma and risk-based tools.
Provide technical support to Drug Substance manufacturing operations, including cell expansion, bioreactor, and downstream processes.
Coordinate and execute technical deliverables to support project execution and product launch.
Prepare, review, and update GMP documentation, including batch records, SOPs, and technical reports.

Requirements

bachelor's

equipment qualification

technical writing

cell culture

gmp

deviation mgmt

Bachelor’s degree in Engineering, Science, or a related technical discipline.
Hands-on experience with equipment qualification and manufacturing support activities.
Proven technical writing capability and attention to detail.
Experience supporting Drug Substance operations, including cell culture and downstream processing.
Knowledge of GMP requirements and regulatory guidelines, including Annex 1, desirable.
Minimum of 3 years’ experience in a GMP environment within biological, vaccine, or pharmaceutical manufacturing.
Experience in start-up or project-based manufacturing environments is advantageous.
Strong experience in deviation management, investigations, and data-driven root cause analysis.

Benefits

Information not given or found

Training + Development

Information not given or found

Interview process

Information not given or found

Visa Sponsorship

Information not given or found

Security clearance

Information not given or found

Company

Overview

Founded in the heart of Ireland, Tandem Project Management Ltd. has grown into a key player in delivering high-quality project management solutions across multiple industries.
The company has a proven track record of success in managing large-scale, complex projects, consistently delivering on time and within budget.
Specialising in sectors like industrial, commercial, residential, and transport, Tandem brings expertise to projects ranging from urban developments to large infrastructure projects.
Tandem Project Management Ltd. thrives in challenging environments, with a deep understanding of project intricacies and client requirements.
Their approach is rooted in collaboration, working closely with clients and stakeholders to ensure projects meet all expectations and deliver lasting value.
The firm is known for its hands-on, proactive management style, providing solutions at every stage of the project lifecycle.
With a focus on maintaining robust relationships, Tandem is dedicated to fostering trust and long-term partnerships with clients.

Culture + Values

2017

Continuous Professional Development

The company has been accredited by Engineers Ireland for CPD since 2017, demonstrating a commitment to ongoing professional development and standards.

Repeat Business

Client Loyalty Track Record

The company maintains a strong track record of repeat business, reflecting its ability to consistently deliver exceptional results and build lasting partnerships.

Safety and quality are at the heart of everything that we do.
Openness, transparency and collaboration.
Client‑centred, collaborative approach.
Tailored approach to meet client needs.
Driven by senior team who lead by example in professionalism and commitment.
Lean techniques and value management methods to ensure fit‑for‑purpose outcomes and best value for money.

Environment + Sustainability

42% Reduction

Commitment to GHG Emissions

Targeting a significant reduction in greenhouse gas emissions as part of a science-based approach.

Committed to 42% reduction in Greenhouse Gas emissions by 2030
Established Carbon Action Team to measure, monitor and report GHG emissions annually to the Carbon Disclosure Project
Initiatives include purchasing renewable energy, sourcing sustainably produced goods and services, monitoring and reducing waste
Reducing paper usage, switching to electric company vehicles, ensuring efficient office utilities, seasonally adjusting temperature controls

Inclusion & Diversity

Rating: 4.1/5

Equality, Diversity, and Inclusion

Based on Glassdoor reviews, the company has a strong rating for its commitment to Equality, Diversity, and Inclusion.

Rating: 3.8/5

Culture and Values

Glassdoor reviews highlight the company's overall Culture and Values, reflecting employee sentiment on workplace environment.

Glassdoor reports ‘collaboration, respect, training, teamwork, autonomous working’ as pros
Glassdoor reports ‘management are friendly and respectful’
No public gender-split or DEI quantitative stats published

Articles

Projects

Careers