Biotech Csv Jobs in Virginia (NOW HIRING)

SAP Project Manager Life Sciences & Pharmaceuticals

Vienna,VA, Onsite.

About Devfi

Devfi, Inc. is an SAP services partner to life sciences and pharmaceutical companies. We deliver S/4HANA solutions for global pharma manufacturers, CDMOs, biotech and medical device clients] across the Globe.

Our clients operate under FDA, EMA and MHRA oversight. Every system we touch is validated and every change is auditable that standard is why they choose a specialist partner over a generalist.

The role

We're looking for a project manager who came up through functional work and never lost it. You will run client projects end to end plan, scope, team, schedule, risk while staying close enough to the solution to challenge a design, unblock a fit-gap debate, and know when a functional lead is telling you something is fine that isn't.

Your functional depth spans PP/PP-PI, QM, MM, EWM, SD and PLM on S/4HANA. You won't configure day to day, but you will chair design workshops, arbitrate cross-module decisions, and hold the line on standard-versus-custom when schedule pressure argues otherwise.

This is delivery in a GxP environment: validation shapes how we plan, estimate and release, rather than sitting at the end as a checkpoint.

What you'll do

Project leadership

• Own the project end to end scope, plan, schedule, resourcing, budget, risk and dependency management.
• Lead large blended teams of 35+ resources across Devfi consultants, client staff and offshore delivery centres; set estimation, design review and quality standards, and manage workstream leads rather than every individual.
• Produce the reporting rhythm: weekly status reports to the client project team and monthly reports to steering committee, covering progress against baseline, RAID, budget position and decisions required. Report honestly surface bad news early and with a recommendation attached.
• Own budget forecasting: build and maintain the resource and cost forecast, track actual against plan, explain variance, and give the client and Devfi leadership enough warning to act.
• Build and deliver the presentations that carry the project steering decks, design decision papers, go/no-go recommendations and executive readouts pitched at the audience in the room.
• Run the governance cadence: steering committees, design authority, change control board, release calendar.
• Manage scope with discipline: identify change requests early, quantify the impact, and hold the baseline.

Functional ownership

• Chair requirements and fit-gap workshops across PP/PP-PI, QM, MM, PLM, SD and and adjudicate cross-module design decisions so the solution stays coherent rather than locally optimised.
• Own the quality of functional deliverables process designs, functional specifications for RICEFW, configuration rationale, authorisation and SoD design.
• Keep the manufacturing and quality thread intact: master recipes and routing, BOMs, batch management, inspection plans and results recording, inventory and warehouse execution, order-to-cash.
• Oversee PLM scope where in play specification and recipe management, document management, engineering change management and how those objects flow into the ERP core.
• Govern integration into MES, LIMS, QMS, WMS and serialisation, and own the master data and migration approach.

Validation, testing and go-live

• Deliver to GxP requirements CSV, GAMP 5, EU Annex 11, 21 CFR Part 11 with validation strategy and requirements traceability agreed with client QA before build starts.
• Own the test strategy end to end: unit, SIT, UAT, PQ and regression, with defect triage and release criteria you sign off.
• Lead cutover, dress rehearsals, go-live and hypercare, with rollback positions agreed in advance.
• Stand behind the solution in client audits and regulatory inspections.

What we're looking for Essential

• 13+ years in SAP delivery, with 5+ managing projects or major work streams, following a functional consulting background.
• Deep functional understanding of S/4HANA across PP/PP-PI, QM, MM, EWM, SD and PLM you can read a configuration decision and see its downstream consequences. Depth in several of these and working literacy in the rest.
• Delivery experience in pharma, biotech, medical devices or another GxP-regulated industry, with a practical grasp of CSV and GAMP 5: you can challenge a validation plan, not just approve one.
• Full-lifecycle ownership requirements through hypercare on at least [two] end-to-end implementations.
• Integration and data migration experience across a complex application landscape.
• Fluency in both V-model and Agile delivery, and the judgement to know which the change and the regulator require.
• Track record leading teams of 35+ across functional, technical, client and offshore resources, including managing through workstream leads.
• Disciplined reporting practice weekly and monthly status reporting against baseline, RAID logs and steering-level updates that executives actually read.
• Budget ownership and forecasting on projects revenue,resource planning, actual tracking, variance analysis and forecast revision.
• Strong presentation skills: you build your own decks, and you can take a steering committee through a difficult decision without losing the room.
• Excellent written and oral communication in English precise in writing, credible in front of a client executive, and clear with an offshore teams.
• Stakeholder management to executive level, including defending a design decision under pressure.
• Willingness to travel to Devfi offices or client sites.
• Work towards building the Pipeline of resources for the project Needs & Skill Development.

Desirable

• SAP Solution Manager or Cloud ALM; SAP BTP, CPI and integration tooling.
• Serialisation and track-and-trace (EU FMD, DSCSA), batch genealogy or electronic batch records.
• Integration with MES ([PAS-X, Opcenter]), LIMS ([Lab Ware, STARLIMS]) or QMS ([Veeva, Track Wise]).
• Tech transfer, site-to-site product introduction, brownfield conversion or multi-site template roll out.
• SAP certification in a relevant module; PMP, PRINCE2 or SAFe.