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Validation and Commissioning Expert

2 months ago

Germantown, Maryland, United States Verista Full time
Job Description

**About Verista**

Verista is a leading provider of innovative solutions and services to the life science industry. Our team of experts works closely with top brands to empower growth and innovation, helping researchers, organizations, and companies solve complex healthcare challenges.

**Our Mission**

We are committed to enabling life sciences clients to improve lives by providing world-class solutions and services. Our talented professionals thrive in a team environment, sharing our mission to make a meaningful impact every day.

**Company Culture Guidelines & Values**

  • We empower and support our colleagues to excel in their roles.
  • We prioritize client success at every turn, ensuring their needs are met and exceeded.
  • We have the courage to do the right thing, upholding the highest standards of integrity and ethics.
  • We foster an inclusive environment where colleagues feel respected, engaged, and challenged to grow.
  • We continuously acquire new skills and learn from our experiences to enhance our collective expertise.

**Job Responsibilities**

  • Collaborate with clients' quality representatives to investigate and resolve deviations, ensuring timely completion of root cause analysis.
  • Support clients' change management programs, including authoring proposed changes, executing impact assessments, and documenting results.
  • Develop, edit, and execute technical commissioning, qualification, and validation documentation for standard equipment, systems, and software.
  • Run test scripts, document results, and maintain clear, detailed records of qualification and validation.
  • Adhere to project schedules for all assigned activities, ensuring timely completion.
  • Document impact and risk assessments as part of a team.
  • Complete user interface testing, software verification, and alarm testing on automated systems.
  • Develop, review, and execute testing documentation.
  • Make recommendations for design or process modification based on test results.
  • Read technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
  • Understand capital equipment implementation and process knowledge.
  • Understand validation documents, URS, IQ, OQ, PQ.
  • Verify system drawings, including reviewing and as-built P&IDs and I&C drawings, and verifying electrical schematics with support from an electrical engineer.

**Requirements**

  • Must be willing to work onsite in Germantown, WI.
  • Bachelor of Science in a technical field (engineering, life science, or equivalent) from an accredited institution.
  • Minimum 4 years of technical experience.
  • Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment).
  • Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV protocols.
  • Specific experience with 6 reactors (2,000gal+)/receivers, Filter Dryers, Centrifuges, Core Dryers, Powder handling systems, clean rooms, support facilities, and tank farms preferred.
  • Experience in a pharmaceutical/FDA-regulated manufacturing environment, with a solid working knowledge of cGMP and facility/equipment validation requirements.
  • Excellent oral and written communication skills, including presentations.
  • Ability to write clearly, concisely, and persuasively in a professional environment.
  • Demonstrated ability to interact effectively with all levels of the organization.
  • Demonstrated understanding of risk-based approach to commissioning & qualification.
  • Experience with testing of automated manufacturing equipment/systems (e.g., PLC-controlled).
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
  • Ability to work as part of a team.
  • Strong problem-solving and critical thinking skills.
  • Excellent organizational and time management skills.
  • Strong attention to detail.
  • GMP and Good Documentation Practice.
  • Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
  • Basic skills with EXCEL and PowerPoint.
  • Strong interpersonal skills and clear communication capabilities.
  • Experience with and tolerance for high levels of challenge and change.
  • Experience in GMP-regulated environment.
  • Proven attention to detail and organization in project work.
  • Capable of working on assigned tasks without mentorship.

**Benefits**

Verista offers a competitive compensation package, including performance-based incentive programs, company-paid life insurance, medical, dental, and vision insurance, FSA, DCARE, commuter benefits, supplemental life insurance, hospital, critical illness, and legal insurance, health savings account, 401(k) retirement plan with employer matching, paid time off, holidays, as-needed sick time, tuition reimbursement, team social activities, employee recognition, employee referral program, paid parental leave, and bereavement leave.