2625 Winsor Dr., Eau Claire, Wisconsin 54703
Life Sciences Manufacturing Staffing & Search

ERP Quality & Validation Talent
for Life Sciences Manufacturing

Bridgepoint places contract and permanent professionals responsible for validating, governing, and maintaining enterprise systems in pharmaceutical, biotech, and medical device manufacturing, including the CDMOs and CMOs that serve them.

ERP validation, CSV/CSA, quality systems, change control, and remediation roles for pharmaceutical, biotech, medical device, and CDMO manufacturers.

FDA 21 CFR Part 11 GxP & CSV/CSA ERP Validation Lifecycle Change Control Inspection Readiness
Regulatory Frameworks
GAMP 5 21 CFR Part 11 EU Annex 11 IQ / OQ / PQ FDA CSA Guidance 2022 21 CFR Parts 210/211 GMP / GLP / GCP ICH Q10
What Sets This Practice Apart

ERP validation recruiting built for regulated manufacturing.

Every search is scoped against system criticality, validation lifecycle phase, audit history, and regulatory exposure before sourcing begins. A CSV specialist who has carried IQ/OQ/PQ through an SAP S/4HANA upgrade under active FDA scrutiny is a materially different profile from one who has configured systems outside a GxP environment. We identify that difference through structured assessment, not résumé review.

We screen for documentation quality under manufacturing pressure, direct FDA inspection experience including Form 483 observation response, and the operational judgment that comes from working where a deviation has patient safety consequences. The shortlist you receive reflects that standard.

How We Work

Engagement Models

Staff augmentation and direct hire for pharmaceutical, biotech, medical device, and CDMO organizations.

Staff Augmentation

Qualified validation professionals placed for defined timelines, ERP programs, CSV remediation initiatives, and inspection-critical activities at life sciences manufacturers where permanent headcount is not the right fit.

ERP Upgrades Remediation FDA Response

Direct Hire

Permanent placement for validation leadership, quality systems ownership, ERP governance, and GxP compliance roles requiring deep life sciences manufacturing regulatory experience and institutional staying power.

Validation Leadership Quality Systems

"The people your validated life sciences manufacturing systems depend on."

Bridgepoint

Scoped Against Your Environment

Each search is structured around your validated production systems, GxP regulatory posture, system criticality, and audit history. An SAP QM owner at a pharma cGMP site and a CSV specialist at a CDMO are different searches. We scope them accordingly.

Compliance-Informed Screening

Candidates are evaluated on their operational depth in GxP validated systems. We assess documentation quality, direct FDA inspection interaction, and whether experience was gained inside a regulated manufacturing environment or on the periphery of one.

Responsive to Regulatory Urgency

FDA Form 483 observations, pre-approval inspection timelines, and warning letter remediation commitments operate on fixed schedules. We move quickly against those timelines and maintain the screening rigor your compliance posture requires.

100%
Life Sciences Manufacturing Focus
FDA
GxP, Part 11, and cGMP Environments
2
Engagement Models: Contract and Direct Hire
ERP+
Validated System Expertise Across Platforms
Life Sciences Manufacturing Sectors Served

FDA-Regulated Life Sciences Manufacturing

We serve manufacturers where validated production systems, GxP compliance, and patient safety are operational requirements, not compliance checkboxes.

Pharmaceutical

Drug Manufacturing

Biotech

Biologics & Biosimilars

Cell & Gene

Advanced Therapies

Medical Device

ISO 13485 / QSR

CDMOs / CMOs

Contract Mfg.

GxP Operations

GMP / GLP / GCP

If GxP compliance, validation integrity, or FDA scrutiny is the context, we can help.

Start a conversation about your life sciences manufacturing search. No obligation, complete discretion.