Quality Assurance Validation Engineer
AM Technical Solutions- Who Are We:
AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives. Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers. AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.
Quality Assurance Validation (QAV)- Engineer
AM is looking for an experienced QAV Consultant position for a client, who is an international leader in developing and manufacturing life-changing pharmaceuticals and biologics that are improving the quality and saving the lives of millions of people.
Direct Involvement Opportunities:
- Quality Engineering in the Pharmaceutical and/or Bio Pharmaceutical industries.
- Compliance review of GMP Documentation, including Batch Records
- Propose remediation to identified gaps.
- Initiate and Own CAPAs to remediate gaps.
- Support harmonization of validation program across client sites.
- Revision of Qualification and Validation life cycle documents.
- Generating Decommissioning reports.
- Author/Revise Validation Plans
- Author/Revise Validation SOPs.
- Assist in the investigation and remediation of Quality Events related to qualified equipment.
- Review lifecycle documents such as Impact Assessments, User Requirements, Design Documents, Risk Traceability Matrix, Criticality Assessments, Risk Assessments, Part 11 Assessments, etc.
- Review and Approve Validation plans, protocols, and reports.
- Assess Change Controls for Validation Impact.
- Collaborates with stakeholders, engineers, SMEs, and cross-functional team members in equipment qualification efforts.
- Participates in continuous improvement and validation maintenance efforts.
Qualifications, Skills, And Experience:
- Bachelors degree or equivalent in Engineering, Science, or related discipline
- 8+ years of experience working in a GMP manufacturing facilities role.
- Experience in pharmaceutical or biopharmaceutical/biotechnology cGxP environment.
- Combination of equipment qualification, process validation, computer systems, cleaning, and sterilization is acceptable. QA pharmaceutical experience is also preferred.
- Quality experience with in-depth knowledge of Validation approach, cGxP standards, and Risk-based validation.
- Must have direct experience in the commissioning, qualification, and validation of facilities, utilities, production, laboratory, and support equipment.
- Experience working in cell and gene therapy products is a plus.
- Knowledge of Industry guidelines (ISPE, PDA) US and international regulations (FDA, cGMP, ICH, ISO, EMA) for validation of GMP facilities.
- Must have strong verbal, written, and interpersonal communication skills especially needed to work in a cross-functional environment.