Sr. QA Validation Engineer

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• Engage in work that matters to our customers and the patients they serve
• Learn new skills and enjoy new experiences in an engaging and safe environment
• Strengthen connections with coworkers and the community

Were committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

Job Overview 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).

Responsibilities The responsibilities of the QA Validation Engineer are as follows:

• 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.

Qualifications/Skills

• 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.

Education, Experience & Licensing Requirements

• 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.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.

Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.