28 days old

Manager, Controls & Automation

Baltimore, MD 21202


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.

JOB SUMMARY
The Manager- Controls and Automation within the Engineering, Facilities, Engineering department is responsible for managing a diverse range of Automation projects and people that support the technology aspect for equipment and system. This lead manages the oversight of controls and automations systems for both manufacturing support and strategic planning.

The role also is responsible for engineering and IT support of a pharmaceutical manufacturing plant. This role includes management of plant floor equipment software for lifecycle evaluation/upgrade, ALCOA+ compliance, and IT domain integration. In addition, this role is expected to project manage automation CAPEX projects for facility enhancements/upgrade and support new projects related to all equipment and process areas needed for the manufacture of parenteral pharmaceuticals at Camden fill/finish facility. Additional duties include managing a team for authoring SOPs, work instructions, validation execution support, regulatory audit participation, quality systems audit mitigations, change control management, and plant equipment troubleshooting support.

Most importantly, strong people leadership skills are essential for the leader of this team. This position includes leading a team comprised of technical personnel covering a diverse range of experience and education levels. It is essential that this leader creates and engaging workplace with a strong focus on developing and empowering people. This leader will be involved on relevant steering and core teams from the equipment technology perspective, so as to ensure proper alignment of team resources and prioritization of work.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.


Manage technical aspects of equipment technology for manufacturing existing and new assets, including but not limited to:
Implement process and equipment standards
Strong understanding of plant-based automation platforms such a VMware, Rockwell, and Siemens.
Strong understanding of validation lifecycle
Strong understanding of fill/finish sterile manufacturing processes
Experience working on capital projects of ranging to 50M dollars or more
Ensure appropriate usage of processing technology within production areas
Provide expert advice and support for technical troubleshooting and weak point remediation for equipment, utilities and systems.
Develop training material for technologies and contribute to technical training
Lead and collaborates on the execution of key capital projects at the shop floor level, working with Project Engineering.
Lead development of standards including systems, tools and templates across sites for equipment technology through validation related activities
Management of automation software lifecycle with governing procedures and processes for manufacturing systems
Responsible for Camden Automation software and documentation lifecycles. Creating maintaining plant floor network and system architecture drawings, authoring of governing automation SOPs and process specifically around data integrity.
Management and execution of software upgrades for plant floor equipment
Manage and coordinate activities between global EBSI IT and operations for activities that affect manufacturing systems (i.e patching, switch updates, firewall changes etc)
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
Focus to continually improve processes throughout the manufacturing and packaging areas.
Assists in qualification of equipment / facilities as needed. Specifically, computer systems validation.
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.
Research 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 managements assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelors or Masters degree engineering, Computer Science, Information Technology or related field with a minimum of 8 years of experience in industrial/pharmaceutical engineering/maintenance setting preferred.
Must have experience managing direct reports and demonstrate leadership
Experience running small to midsized engineering projects using a team-based approach.
Must have knowledge of pharmaceutical facility controls and automation systems and how they support process.
Must possess the ability to identify and resolve problems in a timely manner while gathering and analyzing information skillfully.
Must be able to determine and evaluate risk with associated controls and automation systems with respect to product safety
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.

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.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy<> .

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Categories

Industry

  • Biotechnology
Posted: 2022-06-01 Expires: 2022-07-01

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Manager, Controls & Automation

Emergent BioSolutions Inc.
Baltimore, MD 21202

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