Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Manager of Commissioning, Qualification and Validation (CQV) will oversee day-to-day activities including management of the site Commissioning and Qualification program for GxP production equipment, laboratory equipment, Facility, and utility systems at the site. Provide oversight for all personnel or team issues and personnel development. Responsible for cross-functional involvement for on-going qualification program, impact assessments, deviations, CAPAs, and change controls. Will lead, direct, and advise continuous improvement of the department’s area of control and assist in any other area as needed or directed by management. The manager is responsible for the consistent application and maintenance of CQV procedures and testing templates for site projects (both OPEX and CAPEX).
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Responsible for overseeing all day-to-day activities within the functional areas, including performance management.
• Define and communicate metrics used to track performance against department and company goals.
• Set and manage clear operational priorities for the team.
• Responsible for all personnel development and administration within the functional area.
• Author, review and approve technical documents throughout the equipment/system lifecycle from commissioning and qualification through decommissioning.
• Responsible for maintaining the CQV program in a state of compliance.
• Responsible for maintaining updates to CQV platform methods and procedures.
• Manage and perform all Quality System functions for department including impact assessments, deviations, CAPAs, change controls, SOP revisions, and audit responses.
• Participate in regulatory inspection and audit response activities.
• Must comply with all applicable rules and regulations of Emergent and the Pharmaceutical/Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations, and company regulations.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor of Science degree in Engineering or related field
• 5+ years of experience in the biotech industry and 2+ years of management experience.
• Demonstrated knowledge of cGMPs for biotechnology, validation-related topics, and key industry validation approaches (e.g., validation lifecycle approach, ASME BPE, PIC/S ISPE Baseline Guides ASTM E2500, GAMP 5, V-model, etc.). Complementary knowledge of biopharmaceutical and process engineering principles and practices. Working understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements is critical.
• SME in at least three of the following, SIP, CIP, Facility, Utility & Equipment Qualification, Aseptic Process Simulation, Temperature Mapping, QSM Regulatory preparedness & Response, CSV, AIV and Process Validation.
• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles as they relate to validation issues. Experience presenting these outcomes to senior management.
• Strong communication and computer skills (MS Office Suite).
• Good leadership/decision making skills.
• Excellent analytical and problem-solving skills.
• Excellent time management skills and the ability to handle several tasks simultaneously.
• Must be able to provide clear direction while motivating teams.
• Must lead by example through strong work ethics and high standards.
• Experience with capital project commissioning and qualification and 1–2 years of experience in a project management role
• Familiarity with process automation systems and Data Integrity
• Strong project management skills.
• Member of PMI, PDA, ISPE, ASME, or AICHE
• ASQ certifications (e.g., certified quality engineer, quality auditor, manager of quality / organizational
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.