Cleaning Validation Engineer
Reference: | AMC9772 |
Location: |
Carlow
|
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
Cleaning Validation Engineer
AMC197
11 month contract
Carlow
I am currently on the look out for a Cleaning Validation Engineer for a Biopharmaceutical manufacturing plant in Carlow. This is the perfect role for someone with Cleaning validation experience looking for their next contract.
Responsibilities:
- Ensure that site cleaning practices adhere to external auditing standards.
- Act as the Subject Matter Expert (SME) for cleaning compliance activities on-site.
- Coordinate with cross-functional teams to align local Standard Operating Procedures (SOPs) making updates as necessary.
- Monitor and analyze cleaning deviations, creating annual action plans to enhance overall performance.
- Lead cleaning improvement projects, clearly communicating progress on these initiatives.
- Support investigations related to daily cleaning issues, ensuring that Corrective and Preventive Actions (CAPA) are in place to prevent recurrence.
- Participate in or lead the Cleaning Community of Practice, collaborating across four API sites within the company's network.
- Work alongside internal and external stakeholders, including Compliance Owners, to facilitate investigations, implement improvements, manage change controls, and develop CAPAs.
- Lead complex investigations with cross-functional teams by applying analytical and problem-solving skills to identify root causes, assess impacts, and execute process enhancements.
Requirements
- PhD in Chemistry, BE/ME Chemical Engineering, Pharmaceutical Sciences, or related field.e.
- Minimum of 2 years of experience in a similar role within the pharmaceutical industry or equivalent.
- Strong understanding of cGMP regulations and experience in supporting investigations and regulatory audits.
- Excellent communication and collaboration skills, with the ability to lead cross-functional teams and drive process improvement initiative
If you are interested in this or similar roles apply today and Angela will be in touch if you are good fit