Pharmacovigilance Consultant

We are supporting a leading life sciences organisation in North Carolina on a major capital investment who are looking to bring on an experienced Project Controls Consultant to support project execution and performance tracking.

This role will play a key part in ensuring the project is delivered on time and within budget, working closely with project leadership and engineering teams in a GMP-regulated environment.

Key Responsibilities

• Develop and manage project schedules, cost tracking, and forecasting for a large-scale capital project
• Monitor project performance, identifying risks and variances across scope, schedule, and cost
• Support budget management, change control, and reporting processes
• Work closely with project managers, engineering teams, and contractors to ensure alignment on project timelines
• Produce regular project reports, dashboards, and KPI tracking for senior stakeholders
• Implement and maintain project controls processes and best practices
• Support decision-making through data-driven insights and analysis

Requirements

• Proven experience in Project Controls within capital projects (life sciences, pharma, biotech, or similar regulated industries preferred)
• Strong knowledge of cost control, scheduling, and project reporting
• Experience using project controls tools (Primavera P6, MS Project, cost management systems)
• Understanding of GMP environments and project delivery within regulated settings
• Strong analytical skills and attention to detail
• Ability to work collaboratively across cross-functional teams

We are supporting a leading life sciences organisation in North Carolina with a key capital project and are looking to engage an experienced Mechanical Engineering contractor to support project delivery.

This is a hands-on role working within a GMP-regulated environment, focused on mechanical systems design, installation, and commissioning as part of a major site investment.

Key Responsibilities

• Support the delivery of a large-scale capital project within a manufacturing site
• Oversee mechanical systems design, installation, and commissioning (HVAC, utilities, piping, equipment)
• Work closely with project managers, contractors, and cross-functional teams to ensure timelines and quality standards are met
• Review and approve engineering drawings, specifications, and vendor documentation
• Ensure compliance with GMP, safety, and regulatory standards
• Provide on-the-ground engineering support during construction and commissioning phases

Requirements

• Degree-qualified in Mechanical Engineering (or related discipline)
• Proven experience supporting capital projects within life sciences / pharmaceutical / biotech environments
• Strong knowledge of GMP-regulated facilities
• Experience with HVAC, clean utilities, and process equipment
• Comfortable working in a fast-paced, project-driven environment
• Strong stakeholder management and communication skills

We’re currently supporting a major life sciences client on a significant site expansion in North Carolina and are looking to bring in a Construction Engineer to support delivery on the ground.

This role is focused on the execution side of the project, working closely with contractors and site teams to keep construction activities moving, resolving issues as they arise, and ensuring everything is aligned with project timelines and quality expectations.

What you’ll be doing

• Act as a key point of contact on-site between engineering, project management, and construction teams
• Coordinate contractors and ensure work is progressing in line with schedule
• Troubleshoot and resolve site issues, removing blockers to keep the project moving
• Review drawings and ensure construction aligns with design intent
• Support installation activities across mechanical, electrical, and facility systems
• Maintain a strong focus on safety and compliance, particularly within a regulated/GMP environment
• Assist through to commissioning, ensuring a smooth transition from build to operation

What we’re looking for

• Background in Construction, Mechanical, or related Engineering discipline
• Experience working on capital projects, ideally within life sciences or regulated industries
• Strong on-site presence, comfortable working closely with contractors and trades
• Ability to read and interpret engineering drawings and specifications
• Proactive, problem-solving mindset with the ability to keep things moving in a fast-paced environment

• Leading day‑to‑day maintenance, servicing, and engineering support at a regulated GMP site
• Managing and delivering Capex projects (equipment, facilities, site upgrades)
• Providing hands‑on engineering support where required—this is not a desk‑only role
• Ensuring compliance with GMP and supporting audits, documentation, and quality investigations
• Guiding and developing a small engineering team, fostering a proactive and safe working culture
• Supporting sterile/aseptic processes (experience preferred but not essential)
• Owning engineering documentation, maintenance schedules, and technical procedures
• Participating in the on‑call rota and occasional weekend work

• Strong engineering background within a GMP pharmaceutical environment (essential)
• Experience in sterile/aseptic manufacturing (ideal, not essential)
• Practical hands‑on capability - comfortable writing documents and picking up tools
• Proven people leadership or supervisory experience
• Capex project experience alongside maintenance leadership
• Willingness to participate in on‑call/weekend rota
• Someone proactive, adaptable, and eager to lead from the front

• Cleanroom and laboratory expansion projects
• New equipment installations and commissioning
• Site conversions and facility upgrades
• Support to new site build activities
• General CAPEX project execution
• Ensuring GMP compliance throughout all project stages

• Strong background in GMP pharmaceutical engineering
• Sterile/aseptic or Radiopharmaceutical experience highly advantageous
• Proven experience delivering CAPEX / engineering projects in a regulated manufacturing environment
• Ability to hit the ground running with minimal oversight
• Must be comfortable being hands-on and actively involved in on-site activity
• Any mechanical/electrical capability is beneficial
• Must be available within 1 month maximum (no long notice periods)
• Must be willing to be physically present on site (not remote)

• Provide regulatory and QA oversight across multiple licensed sterile manufacturing sites, ensuring consistent GMP, GDP and MHRA compliance.
• Act as the primary contact for regulatory authorities, supporting inspections, audits, submissions and ongoing compliance commitments.
• Lead regulatory activities for commercial and IMP products, including review of IMPDs, pre‑submission work, post‑approval activities and clinical trial supply documentation.
• Maintain and manage site licences, variations and regulatory submissions.
• Support and advise site teams on quality and regulatory improvements, inspection readiness and continual improvement initiatives.
• Oversee harmonisation of quality systems including deviations, CAPAs, change control, documentation and risk management.
• Provide QA input into product development, validation, technology transfer and sterile processes.
• Contribute to implementation of a new electronic Document/Quality Management System.
• Collaborate with QA, QC, Operations and QP teams across the UK network.

• Degree or higher in a scientific, quality or regulatory discipline (or equivalent experience).
• Minimum 5 years’ Regulatory Affairs experience, including IMP and clinical trial supply exposure.
• Strong knowledge of UK/EU GMP, MHRA expectations and GxP compliance.
• Experience in radiopharmacy, sterile manufacturing, aseptic processing or related environments (highly desirable).
• Some Quality Assurance experience, capable of supporting QA initiatives and projects.
• Experience working across multi‑site operations and regulatory inspections.
• Excellent communication, organisation and stakeholder‑management skills.
• Self‑motivated, detail‑oriented and able to work proactively and independently.
• Proficiency in Microsoft Office applications.