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Process Engineer III, Manufacturing Sciences & Technology

Genezen · Lexington, MA

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Level
Senior
Team
Process
Base pay
$105k–$130k
Degree
Preferred
Experience asked
8+ years
Industry
Pharma & life sciences
Posted
30+ days ago

The role in 30 seconds

A senior process role at Genezen (pharma & life sciences) in Lexington, MA. Chromatography, filtration, TFF, buffer generation, drug product filling).

They ask for
8+ years · degree preferred
Tools it names
Root cause, FDA / GMP, Validation (IQ/OQ/PQ)
Base pay
$105k–$130k
Day to day
some off-shift / weekend coverage

Read from the posting. The full description is below.

How this role compares

Against 28 other live process postings in Massachusetts.

Base pay
About 8% below similar roles

Typical $108k–$149k, from 13 postings that list pay.

Experience asked
More than usual (8+ vs 5+)

Similar roles usually ask 5+ years.

Skills these teams ask for most

  • ✓ Root cause 48%
  • Team leadership 34%
  • ✓ Validation (IQ/OQ/PQ) 24%
  • Robotics 24%
  • Automation 24%
  • SPC 24%

✓ = this posting asks for it too. % = share of similar postings that mention it.

Stands out: this posting asks for FDA / GMP, which few similar roles mention. If you have it, lead with it.

It asks for 8+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

Off-shift / weekend coverageLifts up to 10 lbs

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. 1

    Pick 2–3 people on the Process team at Genezen

    Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.

  2. 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. 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 does off-shift and weekend coverage work?
    • How did you land the job? What stood out in your interviews?
  4. 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. 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.

This plant: Genezen in Lexington

7 other open roles at this site.

All 8 roles at Genezen →
Full description from GenezenAs posted on their careers site.Show

Job summary

The MSAT group plays a critical role in successful manufacturing of clinical and commercial products. The person in this role assists in the transfer of technologies, process validation and cGMP manufacturing of products. This individual will contribute as a core member of various cross-functional teams, and interacts extensively with other departments within Genezen, including Process Development, Manufacturing, Engineering, Quality, and Regulatory Affair etc..

JOB

Responsibilities

  • ◆Supports downstream processing unit operations for process implementation, data collection, data analysis, and real time troubleshooting (i.e. chromatography, filtration, TFF, buffer generation, drug product filling)
  • ◆Assist technology transfer to GMP manufacturing by reviewing process description documents, technology transfer reports, reviewing master batch records, and providing on-floor support for transfer operations
  • ◆Assist manufacturing technical support, including process trouble-shooting, root cause analysis and investigation on process and/or quality discrepancies and deviations during GMP productions, change controls and CAPAs
  • ◆Support plan and execution of process/product life cycle management, including continuous process improvement to improve robustness/capacity/productivity, and to increase level of safety and/or compliance
  • ◆Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)

Requirements

  • ✓Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner
  • ✓Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)
  • ✓Criminal background check required
  • ✓Other duties as assigned

On-the-job experience

5-8 years of relevant experience in gene therapy or other biotechnology industry

Essential

Experienced project management skills

Essential

Show full description ↓

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Working at genezen

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

Essential/Desired

BS/MS or degree in Engineering or other related scientific discipline preferred

Skills / abilities

Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal

Essential

Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing preferable in the area of viral vaccines or gene therapy

Essential

Experience with technology transfer and GMP manufacturing technical support is preferred

Essential

Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems

Essential

Strong communication skills, including writing and oral presentations

Essential

Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner

Essential

Ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands

Essential

Pro-active attitude, flexible, professional, independent and a team player

Essential

Physical demands

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

  • •Regularly sit for long periods of time

Movement

  • •Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
  • •Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

  • •Frequently lift and/or move up to 10 pounds
  • •Occasionally lift and/or move up to 25 pounds

Vision

  • •Frequently utilize close vision and the ability to adjust focus

Communication

  • •Frequently required to communicate by talking, hearing, using telephone and e-mail

Genezen's cures value-based competencies

C ommitted to Science

We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients

We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations

We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity

We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners

We are committed to being a proactive, collaborative, creative and open-minded partner.

Genezen's benefits

  • •Paid vacation days, amount based on tenure
  • •Paid sick time
  • •10 observed holidays + 2 floating holiday + 1 volunteer day
  • •401(k) plan with company match up to 6% of salary
  • •Share Appreciation Rights
  • •Choice of several healthcare plans
  • •FSA and HSA programs
  • •Dental & vision care
  • •Employer-paid basic term life/personal accident insurance
  • •Voluntary disability, universal life/personal accident insurance
  • •Accidental Death & Dismemberment (AD&D) Insurance

Additional details

  • •Nothing in the job description for this role restricts manag

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