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 Manufacturing Science and Technology Engineer is responsible for engineering, operational SME support, and CAPEX management for facility enhancements and support for client related projects related to all equipment and process areas needed for the manufacture of parenteral pharmaceuticals at Camden fill/finish facility. Additional duties include authoring SOPs, work instructions, validation execution support, regulatory audit participation, quality systems audit mitigations, change control management, and plant equipment support.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Comply with cGMP regulations, adhere to company policies, and adhere to SOP and Batch Record directions.
• Manage and coordinate with site project manager on client specific projects, such as custom equipment and/or manufacturing processes.
• Manage small to mid-size CAPEX projects valued at 1M or less.
• Author User Requirement Specifications, while being able to effectively review other validation lifecycle documentation such as functional specifications, hardware design specifications, software design specifications, etc.
• Lead core project teams, maintaining adherence to scope, budget, and timeline.
• Management of vendors to obtain quotes, and necessary information to key stakeholders
• Provide technical support during manufacturing activities to Facilities and Maintenance team when necessary.
• Focus to continually improve processes throughout the manufacturing and packaging areas.
• Develops and writes SOPs and work instructions for new facility and production engineering projects.
• Assists in qualification of equipment / facilities as needed.
• Assists and carries out equipment and process related training to employees from all departments.
• Assists all department with SME knowledge and appropriate corrective actions for audit and deviation observations.
• Compiles, analyzes, draws conclusions and provides written documentation related to the maintenance and validation lifecycle of production systems.
• Specification creation, procurement, construction management, repair of production and facilities equipment.
• Researches new technologies and procedures to enhance production and performs engineering design evaluations.
• Applies creative and sound troubleshooting techniques to generate timely solutions to problems.
• Assignments are broad in nature, requiring originality and ingenuity, and rely on collaboration, limited experience and judgment to plan and accomplish goals.
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
• Bachelors in Engineering or related field preferred or commensurate with experience.
• 3-5 years of experience in industrial/pharmaceutical engineering/maintenance setting preferred.
• Experience running small to midsized engineering projects using a team based approach.
• Knowledge of 2D and/or 3D electronic drafting preferred.
• Must possess the ability to identify and resolve problems in a timely manner while gathering and analyzing information skillfully.
• Proven track record of applying broad knowledge of engineering principles, practices and procedures to the completion of moderately difficult assignments.
• Experience in MS Project and Visio including all other Microsoft Professional.
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.