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9475
Contract

Validation Engineer (2 openings) - 8892329

Location: San Diego, California

Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:

 

Date Posted: 1/17/2019

Hiring Organization: Connexion Systems & Engineering

Job Title: Valdation Engineer

Industry: IT

Location: San Diego, CA 92101

Employment Type: Full Time, Contract

Pay Range:  Open  

Duration:  6 months +

Job#:bh9475

 

Validation Engineer

Duties:

  • The Validation Engineer supports validation activities related to facility, manufacturing process, cleaning process, equipment, critical utilities & computerized systems.
  • These will encompass new facility/equipment/process, process & equipment changes & periodic requalification/revalidation.
  • The incumbent prepares validation plans, protocols, test scripts & reports throughout all stages of validation lifecycle. 
  • Furthermore, the incumbent will be responsible for coordination & execution of validation activities & be expected to play a key role in developing & driving risk based validation approach during essential stages of product lifecycle including process design/control strategy development, technology transfer, equipment/utilities commissioning & qualification (C&Q), process performance qualification (PPQ), continued process verification (CPV), process control/risk management, & product decommissioning.
  • Perform qualification of manufacturing equipment, facility & utility systems (including CIP/SIP qualification), cleaning validation, & process validation.  Scope of responsibilities includes drafting of qualification protocols & summary reports, field execution, & data analysis.
  • As needed coordinate & provide directions to contract personnel performing validation activities.
  • Support the development & execution of FATs, SATs, DQ, IQ, OQ, PQ, & other relevant life cycle documents leveraged to support validation effort.
  • Support the development & update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports.
  • Support cleaning & sterilization (including CIP/SIP, manual cleaning, steam sterilization & dry heat depyrogenation) development activities.
  • Support periodic requalification & revalidation effort.
  • Work independently & directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC & QA.
  • Support gap assessment/closure, corrective actions, & compliance remediation related to Validation

Skills:

  • Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation & Process Validation.
  • Familiar with applicable domestic & international GMP regulations impacting validation requirements (e.g. 21 CFR 210).
  • Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, ISO 14971, ASTM E2500, & applicable PDA Technical Reports).
  • Experience with customer & regulatory inspection.
  • Strong understanding of quality risk management principles, including best practice in risk based C&Q approach.
  • Hands on validation experience in developing validation documentation & field execution.
  • Project Management experience is a plus
  • Familiarity & demonstrated knowledge of biologics manufacturing processes, including fermentation, purification & bulk filling processes.
  • Ability to work independently in a matrix team environment, influence team decisions & exercise sound judgement in determining compliant & robust validation approach.
  • Ability to multi-task with demonstrated track records in meeting deliverable timelines.
  • Must demonstrate the ability to think critically & analytically with acumen for trouble-shooting & problem solving.
  • Good interpersonal skills & accountable with excellent verbal & written communication skills.
  • Ability to function effectively & independently in a fast-paced & dynamic environment.
    Self-motivated & willing to tackle assignments & development opportunities outside of job scope as needed.
    Ability to interpret engineering & facility drawings such as facility layouts, blueprints, material/process flow diagrams & equipment P&IDs.
  • Expert Microsoft Word / PowerPoint & Intermediate Microsoft Excel skills are required.
  • Understanding of basic statistics, acceptance sampling & familiar with statistics software such as Minitab & JMP
  • Strong team player
  • Hands on experience with facility/equipment/utility qualification, cleaning validation, process validation & sterilization validation experience (steam sterilization & dry heat depyrogenation) in GMP environment is required.
  • Hands on experience with CIP/SIP cycle development & qualification is required.
  • Automation & Part 11 validation experience is a plus

Education:

Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus.

English fluent in speaking / writing

Minimum 5+ years of relevant validation experience in regulated industry

The engineer is expected to be proficient in at least 2 of 7 validation core expertise

Validation Core Expertise: 

  • Facility Qualification
  • Equipment Qualification
  • Utilities Qualification
  • Cleaning Validation
  • Process Validation
  • Sterilization Validation
  • Computerized System Validation 

Required:

  • EQUIPMENT VALIDATION
  • SYSTEM VALIDATION
  • PROCESS VALIDATION

 

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

                 

Contact Info:                                                                                                                                             

 

ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776

jobpostings@csetalent.com