Manager, QA Equipment/Facilities/Computers
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.
I. JOB SUMMARY
The QA Manager will be responsible for the programs and activities related to the lifecycle of equipment, systems and facilities. This includes the planning, execution and documentation review and approvals of all capital projects, validation, calibration and facilities activities, to ensure that all cGxP instruments, equipment and systems are maintained in a calibrated and validated state. This position includes supervision and personnel development. The responsibilities also include data integrity knowledge and management. The position requires thorough 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
• Provide leadership and supervision including:
o Exemplify strong and effective communication
o Constructive and goals-based feedback
o Employee tailored personnel development
• Plan, schedule and coordinate activities related to Quality reviews and participation with associated with calibrations, work orders, cycle driven maintenance and validations.
• Participate in capital projects for facilities, utilities and production equipment from conceptualization through commissioning and validation hand-off
• Lead or participate in continuous improvement initiatives
• FAT/SAT participation of new equipment and systems as needed
• Work cohesively with MS&T and Engineering & Facilities department on projects such as shutdown activities, introduction of new equipment and systems, facility upgrades
• Participate in site and organization harmonization regarding data integrity plan implementation and maintenance of program (i.e., assists with creation of configuration specifications, process flow models)
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelors Degree in science or engineering from an accredited university or college, or the equivalent education and experience
• A minimum of ten (10) 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
• Five (5) or more years of supervisory/team leadership and performance management experience
• 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
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.