We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I. JOB SUMMARY
The Specialist I role will be responsible for activities related to the lifecycle of equipment, systems, and facilities. This includes the execution and documentation review and approvals of projects, validation, calibration, and facilities activities to ensure that all cGXP instruments, equipment and systems are maintained in a calibrated and validated state. The position requires understanding of data integrity and 21 CFR Part 11 requirements. Role requires working with cross functional teams to identify computerized needs for new systems, upgrading systems and decommissioning to ensure proper equipment is used and compliant. The individual will provide support to ensure change management, CAPA, deviations, training, Good Documentation practices, SOP and IT systems reviews are conducted in accordance with established policies and procedures. The position requires strong technical knowledge of computerized laboratory and enterprise systems, GAMP processes, and risk management.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Provides technical quality review and approval of documents, qualification documents related to the Quality Systems.
• Review and approval of calibrations and other facilities and equipment related documents to support Quality Systems.
• Represents Quality in key decision-making regarding requirements for CAPEX and validation projects.
• Reviews and approves validation, technical documents, facilities, and maintenance documents i.e., work orders, calibrations, preventive maintenance.
• Manages the site change control program regarding new product introduction, equipment, and facilities.
• Has a broad expertise or unique knowledge, uses skills to contribute to development of company objectives. Achieves goals in creative and effective ways.
• Serves as change agent for continuous improvement within the scope of work.
• Frequently interacts with direct manager and other cross functional peers to gain alignment on sound quality decisions.
• Provide support during regulatory and internal inspection activities as needed.
• Coordinate/lead cross-functional teams in process mapping and other exercises designed to facilitate process and system understanding.
• Must work independently and manage time.
• Must be detail oriented and conduct thorough reviews and approve documents on behalf of Quality Systems.
• Review and approve other documents as needed.
• Support and partner GMP departments across the site
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s degree in science or engineering from an accredited university or college
• A minimum of seven (7) or more years of relevant cGxP experience in a biopharmaceutical or life sciences development or manufacturing environment in calibration, validation, operations, engineering, or any combination thereof
• Experience with investigations into deviations and determination of impact, root cause, and corrective actions
• Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, CIP skids, autoclaves, parts washers, HVAC systems, building chillers, clean steam generators, WFI generation, storage and distribution, RODI water system, and Temperature Controlled Units (e.g., refrigerators, freezers, and incubators) is an advantage.
• Demonstrated success in independent judgment, technical proficiency, and collaboration with others in a cGMP environment.
• Must be a team player and able to work cross-functionally in a matrixed environment.
• Must have excellent written and verbal communications skills.
• Excellent organizational and interpersonal skills.
• Ability to work as part of a high performing team and collaborate effectively with staff at all levels, and across all functions
• Demonstrated ability to manage multiple activities while maintaining a high level of organization
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision
• Ability to make independent sound decisions and independently manage priorities in alignment with department and company goals
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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.