CSV Engineer - pharma

  • Full-time

Company Description

MEDVACON is assisting our leading pharmaceutical client to hire a full-time/perm

CSV - Computer Systems Validation professional.

Let's start with the extra's! This leading company holds nothing back when it comes to employee benefits.

  • Medical, dental and vision benefits effective day one of employment [wow!]
  • Generous 401K match and Paid Time Off accrual
  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • 19 days of PTO + 8 paid holidays
  • Several Employee Resource Groups focusing on D&I
  • Dynamic, fast-paced work environment
  • Employee Stock Purchase Program
  • Positive working environment focusing on continually improving processes to remain innovative
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
  • Competitive salary with bonus potential
  • Community engagement and green initiatives
  • Tuition Reimbursement – Let us help you finish your degree or earn a new one!
  • GymPass program to promote overall physical wellness
  • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

 

 

 

 

Job Description

Now for the work...

Lead computer system validation projects related to authoring and executing specifications and validation documentation for process equipment/systems, laboratory automated instruments/equipment and systems according to the GAMP5 Validation Life Cycle.

Documents CSV Plan, System Requirement Specification (SRS), High Level Risk Assessment (HLRA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, Data Integrity Assessment of the systems, and Audit Trail review.

Qualifications

  • Bachelors or Masters degree in Computer/Electrical Engineering or other relevant Science Field with 5+ years in a CGMP-related industry with at least 3+ years of Computer System Validation experience in a cGMP pharmaceutical/nutraceutical regulated industry and 21 CFR Part 11 compliance (world CSV regulations).
  • In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines
  • Experience with the following applications/systems is preferred: Wonderware/OSI-PI (or other similar systems), WinCC, Allen Bradley PLCs/equipment (RSView, PanelView, RSLogix), ladder logic programming.
  • Ability to work effectively under pressure, handle multiple projects and meet deadlines
  • Strong verbal and written communication skills, good decision-making skills and time management skills is a must; ability to interface with all levels of the organization
  • Ability to lead Computer System Validation projects for the site
  • Ability to write technical documents (like Validation plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report etc)

The client name is confidential right now however, the name will be shared during your interview process.

Be part of a leading pharma company working on innovative and challenging work. If your background aligns with the job and requirements, apply! A member of our talent team will reach you asap.

Additional Information

NO AGENCIES!  Please do not submit candidates.

Please attach a WORD resume to your submission

All of your information will be kept confidential according to EEO guidelines.