Process Engineer for manufacturing OT (hybrid)
SpiraTec AG · Raleigh, NC
- Level
- Engineer
- Team
- Process
- Degree
- Required
- Industry
- Industrial
- Posted
- 3 days ago
The role in 30 seconds
An engineer-level process role at SpiraTec AG (industrial) in Raleigh, NC. Collaborate with existing and new clients to understand their requirements and support the implementation of Industrial OT (such as MES, PIMS, and Historian systems) activities and support services to meet their needs.
- They ask for
- degree required
- Tools it names
- FDA / GMP, Validation (IQ/OQ/PQ), Automation, MES
Read from the posting. The full description is below.
How this role compares
Against 28 other live process postings in North Carolina.
- Experience asked
- Not stated
Similar roles usually ask 5+ years.
Skills these teams ask for most
- Root cause 28%
- SPC 28%
- Six Sigma 24%
- ✓ FDA / GMP 21%
- Tooling 21%
- DOE 21%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for Validation (IQ/OQ/PQ), which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Process team at SpiraTec AG
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Is the work mostly new product launches or sustaining existing lines?
- How much time do you spend on the floor versus at a desk?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
Full description from SpiraTec AGAs posted on their careers site.ShowHide
responsibilities
- ◆Collaborate with existing and new clients to understand their
requirements
and support the implementation of Industrial OT (such as MES, PIMS, and Historian systems) activities and support services to meet their needs.
- ✓In an agile environment, you support the implementation of projects on time and within budget, and yo support the design, development, installation, and commission of industrial IT/OT solutions including after-market support.
- ✓You support the implmentation of technologies for Industrial IT and advise on the qualification and validation of pharmaceutical equipment and computer systems according to current quality standards such as 21 CFR Part 11 and GAMP5.
- ✓In systems of production-related OT (MES/MOM) you map productions processes and apply relevant industrial standards (ISA95, OPC UAS, etc.).
- ✓Act as the primary point of contact for clients and stakeholders and manage client relationships effectively and participate in the development of proposals and presentations to potential clients.
- ✓You support to ensure compliance with quality standards, prepare workshops/training sessions and collaborate on the creation of system and qualification documentation.
What we appreciate about you
Required Skills
- ✓You have an academic degree in Computer Science, Engineering, or other sciences.
- ✓You have experience in manufacturing OT consulting and implementation, with a focus on the pharmaceutical industry.
- ✓You are a team player who enjoys working in a dynamic project environment and have experience in software engineering and with production-related IT/OT solutions.
- ✓knowledge of GxP manufacturing and regulatory regulations and
requirements
for biologics/pharmaceuticals.
- ✓Some travel is required for Customer site.
requirements
engineering as well as in vertical MES integration (ERP, automation, LIMS, logistics) is an advantage.
- ✓Experience in Werum PAS-X MES, Emerson Syncade, Siemens OPCENTER or Aveva PI systems is a plus.
Show full description ↓Show less ↑
Within the SpiraTec Group, SpiraTec Solutions Inc. is the specialist for automation and IT solutions in the process industry in North America. With locations in California, Arizona, Ohio, and North Carolina, we support companies in the (bio)pharmaceutical, chemical, and petrochemical industries in the digital transformation of their production processes. As part of a global company, we combine international engineering expertise with local implementation skills—creating ideal conditions for your personal development in an innovative environment.
What are your
Desired Skills
- +Experience in process consulting/optimization and
What awaits you at SpiraTec
- •Be part of a future-oriented company and implement innovative solutions with us based on the latest technologies and approaches (digitalization, Industry 4.0).
- •We support our employees individually through training and offer the opportunity to develop into a leadership role.
- •SpiraTec is characterized by a team-oriented work culture, flat hierarchies, short decision-making processes and an open communication culture.
- •We are offering on-the-job training, providing you with hands-on experience and the opportunity to work with experienced engineers and consultants.
- •With us, you will find an agile onboarding and a personal buddy during your orientation period.
Applicants must be authorized to work in the United States at the time of application. We are unable to sponsor or take over sponorship of an employment visa at this time.
Would you like to become part of the team?
Apply quickly and easily via our online application form.