Commissioning, Qualification and Validation (CQV) Engineers
Our Northeast Region (Greater Boston Area / New England) is currently looking to identify several Validation Engineer candidates on a full-time basis to support a variety of different commissioning, qualification and validation related projects with our clients throughout the region.
ValSource will conduct on-site personal interviews in Newton, MA throughout the day on Wednesday, February 26, 2020. Qualified applicant responses to this job posting will be contacted and receive follow up information and details regarding this event and specific location and interview times.
Individual will be responsible for activities related to the start-up, commissioning, qualification, validation 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 DQ, FAT, SAT, IV OV, IQ, OQ, and PQ.
- 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 and lab equipment.
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 may be responsible for both direct execution and supervision of field activities.
- 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.
Three (3) to five (5) or more years of Commissioning, Qualification and Validation (CQV) and/or Quality Assurance Validation (QAV) experience in Pharmaceutical, Biotech, Medical Device or related GMP manufacturing environment preferred.
Prior practical experience at a GMP facility in a Process Engineering, Facilities or Operations role with skills that transfer to CQV duties also considered.
Four-year college degree in engineering or science related curriculum required
Due to the full-time nature of these opportunities with ValSource, employment agencies 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.
ValSource is one of the largest independent Validation Services Company in North America with over 200 full time 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.
ValSource celebrates diversity and innovation. With pride, we display the Women Owned logo. This logo shows that we are a company owned and operated by a woman or women, as certified by the Women’s Business Enterprise National Council (WBENC), the nation’s largest third-party certifier of businesses owned and operated by women in the U.S.
Job Type: Full-time
Salary: $35.00 to $55.00 /hour
- CQV: 3 years (Required)
- Writing SOP's: 3 years (Required)
- Quality Assurance Validation (QAV): 3 years (Preferred)
- Equipment Qualification: 3 years (Required)
- Executing SOP's: 3 years (Preferred)
- Qualification: 3 years (Required)
- Validation: 3 years (Required)
- Commissioning: 3 years (Required)
- Are you able work and support projects in the Greater Boston / New England Region?
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
- Parental leave
- Tuition reimbursement