Construction Engineer (Contract)

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

A clinical-stage biotech is looking for a Pharmacovigilance Specialist to support ongoing safety operations across multiple, ongoing Phase 3 programs. This role will focus on safety case review, vendor oversight, and pharmacovigilance metrics tracking, helping ensure safety data quality and regulatory compliance.

This is a part-time opportunity (~30 hours per week).

What You'll Do

• Support oversight of pharmacovigilance vendors responsible for case processing
• Review ICSRs for quality, accuracy, and regulatory compliance
• Assist with tracking and compilation of pharmacovigilance operational metrics, including regulatory safety submissions and case processing performance.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, nursing, or related field
• 4+ years of pharmacovigilance experience, ideally supporting clinical trials
• Experience with ICSR case processing and case review
• Experience working with PV vendors or CRO safety teams is a must
• Familiarity with MedDRA coding and PV safety databases
• Strong understanding of global PV regulations (FDA, EMA, ICH)

If you’re an experienced PV Specialist looking for a flexible, part-time opportunity supporting innovative clinical programs, please apply or reach out to learn more: cait.dawson@rbwconsulting.com

• 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.