THE POSITION

We are looking for an experienced Project Coordinator with a proven background supporting technical and manufacturing activities in a GMP-regulated Pharma, BioPharma, MedTech, or related life sciences environment. The role focuses on coordinating, administering, tracking, and delivering regulated project activities, with particular emphasis on manufacturing and technical documentation workflows, review and approval cycles, stakeholder follow-up, and project delivery support.

The successful candidate will support project set-up and day-to-day coordination across technical and manufacturing workstreams. This includes maintaining trackers, coordinating meetings and review sessions, monitoring actions, dependencies, and milestones, supporting sample shipment and testing-related activities, coordinating chemical risk assessment inputs, and following up with subject matter experts, reviewers, approvers, and delivery leads. The role requires strong organisation, clear communication, attention to detail, and the ability to keep technical project information current, accurate, traceable, and visible in a GMP environment.

The role also includes technical documentation and document control support, including coordinating document updates, managing review comments, supporting approval readiness, and helping ensure documentation is clear, accurate, traceable, and aligned with applicable GMP, client, and regulatory expectations.

EMPLOYMENT TYPE

Permanent full time.

LOCATION

Headquartered in Cork, hybrid role with remote and flexible working arrangements available.

KEY RESPONSIBILITIES

Project Coordination

Support project set-up activities, including project trackers, document repositories, working folders, meeting schedules, review calendars, templates, and administrative controls.
Maintain action logs, decision logs, milestone trackers, review trackers, RAID log inputs, and other project administration artefacts as directed by the Project Manager or delivery lead.
Coordinate project meetings, workshops, SME interviews, documentation review sessions, and client touchpoints, including agenda preparation, minute-taking, action capture, and follow-up.
Track assigned activities, dependencies, review dates, testing milestones, sample shipment requirements, chemical risk assessment inputs, and action owners, escalating slippage, blockers, unclear ownership, or conflicting inputs as needed.

Regulated Project Delivery Support

Support regulated project activities in areas such as GMP documentation, sample shipment coordination, laboratory or testing follow-up, chemical risk assessment coordination, and review/approval workflows.

Work with SMEs, regulatory, quality, project, and technical teams to gather updates, confirm status, clarify ownership, and progress agreed actions.

Prepare concise status inputs, progress summaries, review-cycle updates, and delivery reports for inclusion in wider project reporting.

Escalate risks, blockers, dependencies, overdue actions, unclear requirements, or competing priorities to the appropriate project or delivery lead.

Documentation and Review Support

Coordinate document review and approval cycles, including reviewer follow-up, comment tracking, version status, sign-off readiness, and closure of agreed actions.
Support the preparation, update, formatting, routing, and control of project documentation in line with client requirements and applicable regulated-environment expectations.
Help ensure documentation is clear, accurate, traceable, and ready for review, approval, or controlled release where required.

ESSENTIAL REQUIREMENTS

Bachelor’s degree in Biochemistry, Biotechnology, , Chemistry, or related Life Sciences field.
2+ years’ experience supporting technical or manufacturing activities in a GMP-regulated Life Sciences, Pharmaceutical, BioPharma, MedTech, manufacturing, or engineering environment.
Understanding of the steps involved in Pharma API and DP manufacture.
2+ years’ experience in project coordination and administration, programme coordination, PMO support, or documentation coordination across technical or manufacturing workstreams in a regulated environment.
Strong project administration skills in a GMP-regulated technical or manufacturing environment, including accurate tracking of actions, dependencies, milestones, review cycles, stakeholder follow-up, and controlled documentation.
Strong organisational skills with the ability to manage multiple activities, deadlines, stakeholders, and follow-up actions.
Experience coordinating with manufacturing, technical, quality, regulatory, laboratory, and project stakeholders to clarify ownership, progress actions, and support delivery in a GMP-regulated environment.
Excellent written and verbal communication skills, including the ability to prepare clear minutes, concise project updates, and accurate follow-up communications.
Experience using Microsoft Office tools, document repositories, content management systems, or document control platforms.

DESIRABLE REQUIREMENTS

Familiarity with Nitrosamine formation, sources of contamination, HA regulations and/or risk evaluation process.
Familiarity with method validation and CPV processes.
Familiarity with GMP, GxP, FDA, EMA, ISO, or other regulated quality and compliance frameworks.
Familiarity with regulated project workflows such as sample shipment, laboratory/testing coordination, risk assessment support, or similar GMP project activities.
Familiarity with controlled document workflows, document control platforms, version control, or controlled release processes.
Familiarity with project reporting, dashboard-driven status updates, or data visualisation tools, such as MS Project.
Understand foundational AI concepts, including how AI retrieves and processes information.
Apply best practices to content structure that ensures reliable AI retrieval and generation.
Apply foundation prompting best practices.
Create and evaluate content lifecycle process maps.
Identify and evaluate potential automation opportunities within a content lifecycle or process.

DEVELOPING REQUIREMENTS

AI and Automation

Understand foundational AI concepts, including how AI retrieves and processes information.
Apply best practices to content structure that ensures reliable AI retrieval and generation.
Apply foundation prompting best practices.
Create and evaluate content lifecycle process maps.
Identify and evaluate potential automation opportunities within a content lifecycle or process.

WHAT’S IN IT FOR YOU?

When you join our team, you will become part of an open and communicative culture. Altuent was founded on the principle that all communication, no matter how technical, is about people. We put that into practice by ensuring everyone on our team is valued, included, and supported. We also offer you:

Career progression opportunities in the form of:

Getting involved in projects outside of your area of expertise. We pride ourselves in creating opportunities for our team members to gain experience in activities and fields that they are interested in.

A good benefits package that consists of:

The opportunity to participate in the company pension scheme.
Participation in the Altuent Sick Pay scheme.
Participation in the VHI/Altuent Group health insurance scheme.
Participation in the TaxSaver Commuter Ticket scheme.

ABOUT ALTUENT

Altuent helps organisations transform content into trusted knowledge that people and AI can find, understand, and use with confidence.

We partner with leading organisations in life sciences, technology, and other regulated industries to improve how knowledge is created, governed, managed, and delivered. Our expertise spans technical communication, knowledge management, content strategy, AI readiness, information architecture, localisation, learning, and content operations.

As organisations increasingly adopt AI-powered tools and digital experiences, the quality and structure of their content has never been more important. We help our clients build strong content and knowledge foundations that improve compliance, accelerate onboarding and training, support operational excellence, and enable reliable AI outcomes.

Our team combines deep domain expertise with a practical, people-first approach. Whether supporting regulated documentation, knowledge management initiatives, content transformation programmes, or AI-enabled knowledge solutions, we focus on making complex information clear, accessible, and actionable.

Headquartered in Cork, Ireland, with a global team and client base, Altuent is committed to helping organisations unlock greater value from their knowledge while creating an environment where our people can learn, contribute, and grow.

OUR VALUES

Our company values give us a framework for leadership and daily decision making, they are what makes Altuent a great place to work. Although we hail from all walks of life and speak dozens of languages, our staff share and work towards a common goal and vision for the company. These values are the embodiment of how we as a company and individually behave and present ourselves both internally and externally to our colleagues and our customers.

Teamwork - we support and work for each other.
Integrity -we keep our promises.
Quality -we are dedicated to excellence.
Customer focused –we create value for our customers.
Making a difference –we care.
Measured risk taking –we learn from successes and failure.

Life Sciences Project Coordinator

Benefits

Job Description