Validation Engineer

Validation Specialist / Validation Engineer / CQV Engineer

ValSource is currently looking to identify experienced and technically skilled leaders in Commissioning, Qualification and Validation Engineering to support a variety of exciting projects with clients our clients in the pharmaceutical and biotech manufacturing industries throughout the Greater Boston area and each of our regions in the US.

Responsibilities

Individual will be responsible for activities related to the start-up, commissioning, qualification, validation (CQV) of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Responsibilities are expected to include but are not limited to:

• Collaboratively conduct Risk Assessments and Impact assessments, and establish system boundaries
• Generation, Review, and editing of Standard Operating Procedures. Review and verification of ETOP’s.
• Generation and execution of protocols for Design Qualifications (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Verification (IV), Operation Verification (OV), Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (OQ).
• Experience with the cleaning and sterilization validation of manufacturing equipment.
• Experience with cleaning validation, process and utility systems validation, laboratory systems & equipment, temperature mapping, manufacturing equipment qualification & validation, etc.
• Generation, and supporting the troubleshooting and close out of discrepancies and deviations

Systems and equipment to be addressed will include manufacturing equipment, critical and non-critical utilities, cleaning systems/processes, automation systems, filtration systems, lab equipment, etc.

Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required to control financial and execution related aspects of project.

Project Leaders/Managers may be responsible for both direct execution and supervision of field activities.

Requirements

• Strong organizational skills, excellent writing and communications skills. Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
• Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
• Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.

Experience
Preferred Commissioning, Qualification and Validation (CQV) experience in Pharmaceutical, Biotech, Medical Device or related GMP manufacturing environment preferred. Recent college graduates with an Engineering or STEM related degree also considered for entry level career opportunities.

Prior practical experience at a GMP facility in a Process Engineering, Facilities or Operations role with skills that transfer to CQV duties also considered.

Education
Four-year college degree in engineering or science related curriculum required

Other information
Due to the full-time nature of these opportunities with ValSource, employment agencies, recruiters, or independent contractors need not respond.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Benefits

Benefits of full-time employment with ValSource will include:

• Paid Time Off (PTO) and Holidays
• Medical / Dental / Vision Insurance - premiums 100% paid by ValSource for Employee to Family level coverage
• Basic Life / Short- and Long-Term Disability / Voluntary Life / AD&D Insurance coverages
• ValSource 401(k) Plan
• ValSource Employee Stock Ownership Plan (ESOP)
• Paid Maternity / Parental Leave
• Medical Leave Pay
• Tuition Reimbursement / Continuing Education
• Annual Performance Bonus Compensation
• About ValSource

  About ValSource

ValSource is one of the largest independent Validation Services Company in North America with over 350 Engineering, Commissioning, Qualification and Validation employees.  ValSource returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle.  Full-time employees are offered a competitive compensation package that also includes full benefits (medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.

Equal Employment Opportunity:
ValSource provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military, and veteran status.