Senior Specialist – Manufacturing Automation
The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist – Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure. Responsibilities of the Senior Specialist – Manufacturing Automation include the following:
The automation engineer role at the Senior Specialist level will serve as technical SME and capital team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The automation engineer role at the Specialist level will serve as a team member of the MACS Center Basis of Design Phase and will go on to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network.
As the facility is currently under construction, the selected candidate will contribute to automation equipment and software design, system commissioning/qualification, as well as other automation areas critical activities to enable facility startup. The selected candidate is expected to be a key part of the MACS Project Automation Team and foster a culture of collaboration, learning and innovation. This will also require close collaborate with the development engineers & chemists, compliance representatives, and other team member. This role will be part of the broader Enabling Facilities Automation Team supporting facility operations, process development activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities.
Additional Supported Areas
As required and in addition to support of current capital projects the Senior Specialist may provide direct support to other areas such as:
Small Scale Organics Pilot Plant (SSO): The SSO uses an Emerson DeltaV Distributed Control System. The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.
Hazardous Reactions Lab (HRL): The Hazardous Reactions Lab (HRL), or Bldg. 801, uses GE PLC 90-30 processors and Genius I/O blocks. The Graphical interface is an Intellution iFix platform run on redundant SCADAS and seven workstations, with historical data collected on a local historian as well as OSI PI. The B801 High Pressure Lab and Low-Pressure Lab Automation Systems supports Hydrogenation Hazardous reactions using a wide variety of vessels and equipment. The High-Pressure Barricades Cells are divided up into ten cells where each cell is electrically classified as Class 1 Division 2 Hazardous Area, Group B.
Education Minimum Requirement:
Bachelor’s degree in Automation, Engineering, Science, or Computer-Programming related degree with minimum of 8 years relevant experience, or a Masters degree with 5 years of relevant experience
Required Experience and Skills:
- Pharmaceutical Operations experience, in a GMP Pilot Plant, Manufacturing environment or related facility
- Ability to understand, update, design and implement required code modifications in DeltaV
- Experience with automation system design, start-up and/or qualification.
- Experience providing project level direction to contractors and/or third-party vendor staff.
- Knowledge of all of the details of automation including wiring, electrical, device selection and integration
- Experienced problem solver/troubleshooter, skilled in root cause analysis
- Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.
- Experience with Quality Systems
- Experience in supporting compliance investigations and change management.
- Familiarity with US and EU GMP and Safety compliance regulations
- Effective interpersonal and communication skills, both verbal and written.
- Excellent organizational skills to multi-task.
- Desire and willingness to learn, contribute and lead.
- Project Management experience with demonstrated skills.
- Candidate must be able to work independently and as part of a cross-functional team.
- Strong analytical thinking and technical writing skills
- Proficient in MS Office Platform and document storage systems
- A high level of innovation, creativity, and self-initiative
Desired Experience and Skills:
- Experience with DeltaV Live, DeltaV wireless and Charms I/O
- Ability to perform PID tuning of instrumentation & control loops.
- Working knowledge of general OPC interfaces
- Subject Matter Expert on Control Systems
- Understanding of Object-Oriented languages
- Strong background in IT systems; specifically, integration of Automation systems with IT systems
- Networking experience; working knowledge of Enterprise Networking and local control networks.
- Experience providing technical mentorship.
- Experience with coordinating maintenance activities around processing activities to support reliable facility operation.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:$97,680.00 - $153,700.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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