Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Date Posted: 5/14/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Senior Validation Engineer
Location: Boston, MA
Employment Type: Full Time, Contract to Permanent
Pay Range: 49-52/hr. or 100K +
Duration: Contract to Permanent
Senior Validation Engineer
- Very Hands-on with equipment / machinery
- GMP and Pharma experience are a MUST
- 5-10 years of experience in GMP / Pharma environment
The Validation Engineer performs and assists with managing validation supporting activities including, Cleaning Validation, Process Validation, Change Control and review of facilities work orders, calibration and other supporting systems documentation in a GMP manufacturing facility. This individual assures validation, calibration, Change Control and Quality review activities are performed in conformance with applicable company Standards and Operating Procedures, industry best practices and regulatory requirements.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Performs commissioning and qualification in a GMP manufacturing facility. Maintains Validation per Validation Plans and plans for small to large size projects and writes commissioning and qualification/validation protocols, executes protocols and authors reports.
- Reviews and approves external contractor validation documentation following our standards
- Coordinates Change Control activities and performs QA technical reviews of facility work orders and supporting site engineering work.
- Knowledge and experience with Cleaning and Process Validation principles and practices.
- Resolves protocol discrepancies and deviations.
- Reviews peer reports and presents the validation approach and study results to peers and managers.
- Generates validation studies during regulatory inspections and internal audits.
- Generates deviations, CAPAs, root cause analysis, and assists with investigations with Quality Assurance.
- Acts as a Quality member on validation teams, providing support for validation compliance.
- Assists in the conduct of qualification audits of service providers as required.
- Participates in the reviews and approvals of internal and external SOPs as they relate to validation.
- Supports change control assessments.
- Performs SOP revisions, review and approval, develops validation SOPs, validation test strategies.
- Executes activities related to validation plans for small scale to large size validation projects, as well as generating, reviewing and approving validation protocols, supporting documentation and reports.
Responsible for the generation of complex protocols using a risk-based approach that meets current regulatory requirements and industry practices, as well as performing Design Reviews and Qualification, along with Factory Acceptance Testing.
Education and/or Experience:
- Bachelor’s Degree in engineering, science or a related field required.
- Minimum of three to five years of experience working in a cGMP regulated environment required.
- Minimum of five years of operational validation experience in a GMP manufacturing environment required.
- Proficient with data logging systems (such as Kaye/GE Validator, ELAB, Data Trace).
- Basic knowledge of Calibration Activities and Preventative Maintenance preferred.
- Good understanding of FDA and EMA regulations and guidelines.
- Must be trained in GMP Quality systems such as Change Control, CAPA, and Deviation.
- Knowledge with Calibration Activities and Preventative Maintenance.
- Knowledge of risk-based validation approaches that meet current regulatory requirements, and industry practices.
- Must be proficient in MS Office Suite.
When responding to this job posting you MUST include the Job# and Job Title in your subject line.
ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776