Position: Manager, Engineering β Capex Projects
Essential Functions / Responsibilities:
- Lead major Capex projects from concept design, RFP, buildout, commissioning, and handover to users (plans, budgets, schedules, vendor management).
- Manage contractors and engineers to ensure designs/equipment meet company standards.
- Develop/maintain project charters, scope statements, execution plans, budgets, and master schedules across multiple capital initiatives.
- Provide technical oversight for GMP facility systems: civil/structural, mechanical, electrical, plumbing, HVAC, process piping (cleanrooms, HVAC cascade design, CIP/SIP, utility distribution).
- Review/approve engineering deliverables (equipment submittals, P&IDs, equipment layouts) before installation/commissioning.
- Ensure designs and flows comply with Global cGMP requirements.
- Develop and execute commissioning plans as part of the facility lifecycle prior to validation.
- Coordinate construction activities with internal departments to prevent interruptions to operations; collaborate cross-functionally.
- Mentor/coach/train engineers; troubleshoot and coordinate investigations of manufacturing/lab processes.
- Place work orders; assist with vendor communications and maintenance/repair scheduling; coordinate with clients/contract manufacturers/vendors.
- Lead engineering design reviews; participate in audits/regulatory inspections.
- Create/edit/adhere to SOPs, drive process improvements and template standardization.
Qualifications:
- Bachelorβs degree in engineering or related field + 5+ years relevant experience (required).
- 3+ years Capex project experience (required).
- Experience supporting GMP manufacturing operations (required).
- Engineering leadership for small and expansion capital projects (required).
- Equipment/process troubleshooting and repair (required).
- Facility/equipment commissioning and validation (required).
- Pharmaceutical/biotech experience (preferred).
- Valid driverβs license (required).
Skills/Abilities:
- Technical reports, analysis, and presentations; commissioning and IQ/OQ/PQ for GMP equipment.
- Knowledge of quality systems (change control; CAPA, deviations/OOSs; training/document control).
- Working knowledge of GMP, OSHA, 21 CFR Part 11, cleanrooms, biopharmaceutical processing.
- Strong interpersonal, technical writing, communication, and organizational skills.
Benefits (explicitly stated): Medical, Dental, Vision; Health and Financial Wellness Programs; EAP; Life/AD&D; Short-Term/Long-Term Disability; Healthcare & Dependent Care FSAs; 401(k) match; 529; Paid Time Off (11 holidays; exempt unlimited PTO / non-exempt 10 vacation days, 56 health pay hours, 2 personal days, 1 cultural day).
Application instruction:
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).