Headsbase · 2 days ago
Validation Engineer
Fall River, MA
Full-time
Onsite
Mid, Senior Level
4+ years expHeadsbase is a confidential company seeking a Validation Engineer. The Manufacturing Validation Engineer is responsible for creating, revising, executing, and maintaining qualification and validation documentation in compliance with cGMP and regulatory requirements, while collaborating with cross-functional teams to support operational excellence and audit readiness.
Management Consulting
Responsibilities
Create, review, revise, and execute GMP qualification and validation documents
Lead cleaning validation and process validation activities for API equipment and products
Prepare and manage validation documentation including:
URS, FDS, DQ, HDS, SDS, FS
Validation Plans, FAT, SAT, IQ, OQ, PQ
Validation Certificates, PIR, RTM
Support validation of equipment, utilities, computer systems, e-batch records, and e-logbooks
Lead or support deviation investigations, root cause analysis, CAPA, change control, and FMECA
Manage periodic document reviews and Master Control database checks
Defend validation strategies during internal, customer, and regulatory audits
Track, generate, and report validation and performance metrics
Support continuous improvement initiatives and new equipment implementation
Collaborate cross-functionally to ensure compliance with cGMP, GDP, and 21 CFR Part 11
Participate in audits and compliance inspections
Perform other duties as assigned
Qualification
Required
Associate's degree with 4–6 years of GMP documentation experience OR
Bachelor's degree in Science, Biochemistry, Pharmaceutical Engineering, Pharmaceutical Sciences, or related field (preferred)
Minimum 4 years of validation/documentation experience
Minimum 6 years of pharmaceutical or biotech industry experience
Strong knowledge of: cGMP, GDP, 21 CFR
Qualification & validation lifecycle
Cleaning and process validation
Deviation, CAPA, change control
Preferred
Experience in generic pharmaceutical manufacturing preferred
Experience with inhalation products (MDI)
Experience with SAP, Master Control, TrackWise systems
Knowledge of automation in pharmaceutical equipment
Experience with audits and regulatory inspections
Familiarity with statistical tools/packages
Strong Microsoft Office skills (Word, Excel)
Excellent written and verbal communication skills
Strong organizational and time-management abilities
Ability to work independently and in cross-functional teams
Detail-oriented with strong problem-solving skills
Ability to manage multiple priorities in a fast-paced manufacturing environment
Self-motivated with a sense of urgency
Company
Headsbase
At Headsbase, we help organizations strengthen their workforce through modern talent solutions.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase