Sr. Engineer I, Instrumentation & Controls

Reposted 20 Days Ago
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Triangle Trailer Park, Township of Jacksonville, NC, USA
In-Office
93K-121K Annually
Senior level
Biotech
The Role
Provides technical leadership for analytical instrumentation and instrumentation and controls systems supporting pharmaceutical manufacturing and laboratory operations. Responsibilities include troubleshooting, validation, calibration, GMP documentation, capital project leadership, commissioning, qualification, control-system configuration, continuous improvement, regulatory inspection support, and mentoring junior staff. The role works with platforms including DeltaV, PLCs, SCADA, DCS, LIMS, Empower, and LabX while managing project scope, schedules, resources, and budgets.
Summary Generated by Built In

About This Role

The Sr. Engineer I, Instrumentation & Controls serves as a technical expert for analytical instrumentation and instrumentation & controls (I&C) systems supporting pharmaceutical manufacturing and laboratory operations. This role partners across Engineering, Manufacturing, Maintenance, Technical Development, and Manufacturing Sciences to improve equipment reliability, compliance, and operational performance. The engineer will lead troubleshooting efforts, support capital and maintenance projects, oversee commissioning and qualification activities, and drive continuous improvement initiatives across critical facility and manufacturing systems.

What You'll Do

  • Provide engineering and validation support and troubleshooting for Manufacturing Process and Laboratory Analytical Instrumentation including the following systems:

    • Cytiva Filter Integrity Testers, Vi-Cell Blu Cell Counter, Kaye AVS, Lives Temperature and Humidity Dataloggers, Climet Particle Counters, Osmotech XT osmometer, Metler Toledo pH probes (LabX)

  • Author deviations, CAPAs, and change control records in a GMP environment related to analytical instrumentation used throughout the manufacturing site

  • Support in-house and vendor calibrations of analytical instruments and managed scheduling in CMMS

  • Subject Matter Expert in Critical Risk Analysis and System Impact Analysis for analytical instrumentation

  • Support instrumentation related capital and op-ex projects, including scoping, modifications, design reviews, change controls, and validation

  • Develop and maintain site standards for instrumentation, controls, calibration, and metrology systems.

  • Bridge automation and metrology functions by implementing effective equipment control strategies and calibration programs.

  • Lead instrumentation and controls projects from design through implementation while managing scope, schedules, resources, and budgets.

  • Support commissioning, qualification, and startup activities for new equipment and facility upgrades.

  • Utilize and troubleshoot multiple control platforms including Empower, LabX, Siemens Poccelerator, Finesse, DeltaV, PLCs, SCADA, DCS, DAS, and LIMS systems.

  • Partner with cross-functional teams to identify opportunities for process improvements and operational excellence.

  • Mentor I&C technicians and junior engineers to strengthen technical capabilities across the organization.

  • Support regulatory inspections and audits by providing technical expertise and defending engineering practices and procedures.

Who You Are

You are a hands-on engineering professional with deep expertise in analytical instrumentation and controls systems who enjoys solving complex technical challenges. You thrive in collaborative environments, take ownership of critical projects, and are motivated by improving system reliability, compliance, and operational performance. You bring strong technical judgment, excellent communication skills, and a continuous improvement mindset to every project you support.

Required Skills

  • Bachelor's degree in Engineering.

  • 4 years of relevant engineering experience in pharmaceutical, biotechnology, manufacturing, or highly regulated environments.

  • Strong knowledge of FDA GMP and EMA regulatory requirements.

  • Expertise with analytical instrumentation including HPLC, UPLC, pH/conductivity instrumentation, balances, and scales.

  • Experience supporting pharmaceutical manufacturing and laboratory instrumentation systems.

  • Proficiency configuring and troubleshooting instrumentation and control systems, including DeltaV, PLCs, DCS, SCADA, DAS, LIMS, and laboratory instrumentation software.

  • Ability to interpret and troubleshoot control panel wiring diagrams and electrical schematics.

  • Experience authoring and executing validation protocols, deviations, CAPAs, and change controls.

  • Strong project leadership and cross-functional collaboration skills.

  • Excellent written and verbal communication skills.

  • Proficiency with Microsoft Office Suite, SharePoint, and Microsoft Project.

  • Ability to support occasional extended shifts or weekend work as business needs require.

Preferred Skills

  • Experience with low-voltage control panel wiring, troubleshooting, and repair.

  • Additional expertise with facility and utility instrumentation systems.

  • Experience supporting regulatory inspections and defending engineering practices to health authorities.

  • Experience in GMP biotechnology or pharmaceutical manufacturing environments.

  • Validation and commissioning experience for manufacturing and facility systems.

  • Experience leading capital projects and implementing instrumentation upgrades.

  • Demonstrated ability to mentor technicians and junior engineers.

  • Continuous improvement, reliability engineering, or asset management experience.


 

Job Level: Professional


Additional Information

The base compensation range for this role is: $93,000.00-$120,750.00


Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.


Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. 


In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement 
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance 
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit 
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan 
  • Tuition reimbursement of up to $10,000 per calendar year 
  • Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.


At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.


All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.



Skills Required

  • Bachelor's degree in Engineering
  • Four years of relevant engineering experience in pharmaceutical, biotechnology, manufacturing, or highly regulated environments
  • Strong knowledge of FDA GMP and EMA regulatory requirements
  • Expertise with analytical instrumentation, including HPLC, UPLC, pH and conductivity instrumentation, balances, and scales
  • Experience supporting pharmaceutical manufacturing and laboratory instrumentation systems
  • Proficiency configuring and troubleshooting DeltaV, PLCs, DCS, SCADA, DAS, LIMS, and laboratory instrumentation software
  • Ability to interpret and troubleshoot control panel wiring diagrams and electrical schematics
  • Experience authoring and executing validation protocols, deviations, CAPAs, and change controls
  • Strong project leadership and cross-functional collaboration skills
  • Excellent written and verbal communication skills
  • Proficiency with Microsoft Office Suite, SharePoint, and Microsoft Project
  • Ability to support occasional extended shifts or weekend work
  • Experience with low-voltage control panel wiring, troubleshooting, and repair
  • Additional expertise with facility and utility instrumentation systems
  • Experience supporting regulatory inspections and defending engineering practices to health authorities
  • Experience in GMP biotechnology or pharmaceutical manufacturing environments
  • Validation and commissioning experience for manufacturing and facility systems
  • Experience leading capital projects and implementing instrumentation upgrades
  • Ability to mentor technicians and junior engineers
  • Continuous improvement, reliability engineering, or asset management experience

Biogen Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Biogen and has not been reviewed or approved by Biogen.

  • Fair & Transparent Compensation — Pay is generally positioned as competitive and often perceived as fair across roles, with total compensation framed as strong when bonus and equity are included. Compensation sentiment is described as above-average overall, though it varies by function and business cycle.
  • Equity Value & Accessibility — Equity programs are repeatedly highlighted as a meaningful part of the total package, including stock programs and an employee stock purchase plan. Equity and bonus elements are portrayed as important contributors to feeling well rewarded beyond base pay.
  • Leave & Time Off Breadth — Time-off benefits are described as distinctive, including a year-end shutdown and a paid sabbatical after extended tenure. Vacation, holidays, sick time, and personal-significance days are also presented as supportive of work-life needs.

Biogen Insights

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The Company
HQ: Cambridge, MA
9,575 Employees
Year Founded: 1978

What We Do

Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

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