Sr. QA Validation Engineer

Cambrex•Charles City, IA

About The Position

The Quality Assurance (QA) Validation Engineer is responsible for providing Quality Assurance oversight to all site process, equipment, and facility activities to mitigate regulatory risks at CCC. This position will function as site QA Subject Matter Expert (SME) as the leader of an inter-disciplinary team responsible for equipment and procedure development, process execution and improvement and completion of validation studies. Under the direction of site management and cooperation with other disciplines (Production, Process Engineering, Project Engineering, Analytical Development, etc.), the SME will ensure appropriate validation studies are completed in accordance with cGMP requirements, industry standards, and customer requirements and expectations. In addition, this position will provide technical review and approval for change controls (specifically supplier qualification and equipment and facility) and projects (including review and approval of process, equipment, and facility validation protocols and reports)

Requirements

Strong critical thinking skills.
Strong interpersonal and leadership skills, including initiative and strong work ethic.
Ability to effectively lead inter-disciplinary team of personnel responsible for process, equipment and facilities validation, procedure development, process execution and improvement and completion of site validation studies.
Knowledgeable in technical aspects of validation including procedures and practices, validation strategies (including grouping), performing risk analyses and able to assist in performing validation-related investigations.
University degree (or equivalent) as BA or BS in chemistry, engineering, or other scientifically relevant field (i.e., industrial hygiene, pharmacy, etc.).
5+ years of relevant experience working in commercial pharmaceutical manufacturing cGMP environment. Operational understanding of manufacturing equipment function and operation.
Extensive experience working in manufacturing environment and approve procedures and documents.

Responsibilities

Serve as site QA Validation SME
Develop and implement approaches and strategies for validation studies
Assist in development and completion of program timelines
Liaise with clients, customers, and regulatory authorities regarding site equipment and facility program validation; develop CAPA for customer inquiries and audit observations; provide standard statements of compliance; write, review, and approve validation procedures and documents as procedures/records, SOPs, and validation protocols and reports; provide technical assistance with conducting validation investigations and writing and issuance of investigation reports
Provide risk-based analyses regarding product and validation impact assessments
Assist in developing CAPA and assessing CAPA effectiveness
Review of various change controls for impact to the global CCC validation program
Maintain and update Site Master File and Site Validation Master Plan
Review supplier qualification documentations and related change controls
Update the Approved Supplier List on a quarterly basis
Provide QA review and approval for site process, equipment, and facility change controls
Assist in development of cleaning-related procedures and limits.
Other duties relating to departmental mission, not specifically detailed in this section, may be assigned.
All employees are required to adhere to DEA, EPA, FDA, and cGMP regulations as they relate to the operation of the Company, and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly.