layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Validation Engineer III at Strive Pharmacy, Alachua, FL

Position Type:

Full-Time

Key Responsibilities:

Engineering Commissioning
Develop and review technical packages, Engineering Turnover packages, including P&IDs, Process Flow Diagrams (PFDs), and mass/energy balances.
Author User Requirement Specifications (URS) and Functional Design Specifications (FDS) for new process equipment and automation systems.
Oversee the integration of new equipment into existing facility utility infrastructure (HVAC, Electrical, Clean & Non Clean Utilities).
GMP Compliance, Validation & Commissioning
Validation Ownership: Ensure all site project activities align strictly with the Validation Master Plan (VMP) and site Quality Management Systems (QMS).
Change Control & Investigations: Initiation of validation Change Controls, ensuring modifications are risk-assessed and approved by QA before implementation. Perform Root Cause Analysis (RCA) and lead investigations for project/validation deviations.
Engineering/Validation Execution: Evaluation of vendor-supplied validation and engineering documentation packages.Perform documentation gap analyses against cGMP, engineering, and regulatory standards. Author supplemental validation protocols, risk assessments, and mitigation plans to close identified vendor documentation gaps.
Procurement & Turn-key Handover: Manage Commissioning & Qualification (C&Q) through final handover to Operations, coordinating with Metrology to onboard new instrumentation into the CMMS.

Qualifications & Skills:

Education: B.S. in Chemical, Mechanical, Bio-Engineering, or related engineering field.
Experience: 10+ years of engineering and validation experience in a GMP-regulated environment (Biotech, Pharma, or Med Device)..
Technical Knowledge: Strong mastery of ASTM E2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical Manufacturing Systems).
In-depth expertise in aseptic areas, cleanroom classification (ISO 5–8), and automated control systems (PLC/SCADA).
Practical knowledge of ASME BPE standards for bioprocessing equipment.
Proficiency in authoring and executing engineering and validation lifecycle documentation, commissioning and qualification protocols (IQ/OQ/PQ) and final/ summary reports.
Experience with 21 CFR Part 11 compliance and data integrity requirements for computerized systems.
Comprehensive knowledge of risk-based validation approaches (FMEA) and lifecycle management.
Comprehensive knowledge of ISPE Baseline Guide: Commissioning and Qualification (CQV) methodology, including science and risk-based approaches to system lifecycle management.
Software: Proficiency in AutoCAD, MS Project / Smartsheet, and CMMS platforms (e.g., Blue Mountain RAM, Maximo, or Fiix).

Work Environment:

This position is primarily based in an onsite work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities. This role also requires the following:

Must adhere to strict Occupational Exposure Limits (OELs) and NIOSH hazardous drug protocols when weighing, compounding, or packaging Schedule III hormones and other potent endocrine-disrupting compounds.

Required to wear specialized PPE, including respirators and full-body protective suits, for extended periods. Candidates must be medically cleared to wear a respirator and pass standard fit-testing prior to handling active pharmaceutical ingredients.

Willingness to comply with ongoing medical monitoring, including baseline and periodic hormone level testing as part of our commitment to employee health and workplace safety.

Ability to work in active construction zones and mechanical utility spaces.

Occasional travel (up to 5%) for Factory Acceptance Testing (FAT) at vendor sites or external vendor audits.

Ability to work in active construction zones and mechanical utility spaces.

Validation Engineer III

Employer job description

Company Overview:

Mission:

Position Summary:

Location:

Salary:

Position Type:

Key Responsibilities:

Qualifications & Skills:

Work Environment:

Annual Salary

Join Us in Making an Impact:

Benefits/ Perks:

About this listing

Listing check

Before you apply

Similar jobs

Similar jobs