Senior Compliance Engineer - Process Engineering
About the job
- Proven experience specifying and designing process equipment and systems for aseptic environments.
- Perform root cause analysis, define corrective actions, and ensure implementation and follow-up.
- Experience in process and facility engineering with hands-on support for GMP compliance of facilities, utilities, and process equipment, including change controls, deviations, non-conformances, qualifications, and validation support.
- Experience writing procedures and protocols, analysing process data, and producing clear technical reports with conclusions and recommendations.
- Knowledge of HVAC systems, certification, and monitoring.
- Identify improvement projects, create project plans, and participate in delivery to drive efficiency and business outcomes.
- General understanding of project budgeting and basic financial processes.
- Awareness of the department’s role within the broader organization and readiness to lead project teams.
- Experience planning and coordinating validation and scale-up activities, equipment assembly, in-process sampling, reactor use, and preparation of compliance documentation.
- Evaluate analytical results to maintain and improve batch quality.
- Propose and implement new or improved technologies to enhance product quality, manufacturing cost-efficiency, personnel safety, and regulatory compliance.
- Solid knowledge of aseptic fill-finish operations and regulatory requirements (Annex 1 / FDA guidance), and the ability to translate these into technical solutions.
- 4–6 years’ experience in the pharmaceutical, food, or chemical industry.
- Fluent in German and English, written and spoken.
- Provide technical support for operation of process equipment and production in the Fill & Finish pilot plant.
- Lead troubleshooting, corrective action, and documentation efforts for technical issues and non-conformances, collaborating with production teams, equipment suppliers, and Quality Assurance.
- Manage technical changes and optimization initiatives through the change control process.
- Oversee the technical work order system in cooperation with mechanics and Technical Services.
- Deliver training and instructions to operators and staff at system and process level.
- Support evaluation, qualification, and implementation of new technology platforms and processes in an aseptic environment.
- Collaborate across engineering functions locally and within the global engineering organization on cross-functional projects.
- Previous aseptic-fill or sterile manufacturing experience is an advantage.
- Preferred skills include agile decision making, coaching, critical thinking, emerging technologies, engineering, problem solving, process control, process engineering, process improvements, product costing, product improvements, research and development, SAP Product Lifecycle Management, situational awareness, technical research, technical writing, technological savvy, and vendor selection.
About the company
Johnson & Johnson develops prescription medicines and makes medical devices for hospitals, and unlike most big drugmakers, it runs both businesses under one roof. In 2015, its Darzalex became the first antibody drug approved for multiple myeloma, a blood cancer. Its medicines treat cancer, immune diseases such as psoriasis, and mental illnesses such as depression, and patented drugs bring in most of its sales. Its MedTech unit makes heart pumps, catheters that treat irregular heartbeats, surgical sutures, and Acuvue contact lenses. It was founded in 1886 to make sterile surgical dressings, is based in New Brunswick, New Jersey, and spun off its consumer brands, such as Tylenol and Band-Aid, as Kenvue in 2023.
Company Size
10,001+
Company Stage
IPO
Headquarters
New Brunswick, New Jersey
Founded
1886
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Simplify's Take
What believers are saying
- Cancer drugs drive growth: oncology sales rose 17% to $7.4 billion in the June 2026 quarter, 29% of the total.
- Stock grants have gained value: J&J shares rose 58% in the year to September 2026, versus 23% for Pfizer.
- Students have a way in: J&J listed 1,897 open jobs in October 2026, including 201 internships, co-ops and early-career roles.
What critics are saying
- Its key immune drug trails: AbbVie's Skyrizi outsold Tremfya $5.5 billion to $2.0 billion in the June 2026 quarter.
- Orthopedics is leaving J&J: in September 2026, it was negotiating a $20 billion sale to buyout firm Apollo.
- Baby powder suits remain costly: in July 2026, J&J agreed to pay $5.5 billion to end about 76,000 cancer claims.
What makes Johnson & Johnson unique
- Its debt is rated safer than America's: S&P's top AAA rating goes to only two US companies, J&J and Microsoft.
- Employees rank above shareholders: J&J's 1943 Credo lists duties to patients, then staff and communities, with stockholders last.
- Its psoriasis pill is a first: Icotyde, approved March 2026, blocks an immune signal rivals target only by injection.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
401(k) Company Match
Paid Vacation
Paid Sick Leave
Paid Holidays
Remote Work Options
Performance Bonus
Growth & Insights and Company News
6 month growth
-2%1 year growth
-2%2 year growth
-2%Johnson & Johnson shares fell 6% after its medical device sales missed forecasts, even though third-quarter results beat estimates. Revenue was $25.4 billion, above the $25.37 billion expected. Adjusted earnings were $2.59 per share, $0.07 above estimates. MedTech sales rose 2.5% to $8.6 billion, below the $8.71 billion forecast, and marked a second straight quarterly miss. The company blamed the Middle East conflict, European austerity, and pricing pressure in China. Pharmaceutical sales rose 7.7% to $16.76 billion. Net earnings fell to $210 million from $2.12 a year earlier, hit by about $7 billion in talc settlement and deal costs. The company raised its full-year sales outlook to about $101.2 billion and said it is leaning toward spinning off its orthopedics unit, DePuy Synthes, by mid-2027.
Johnson & Johnson's medtech sales rose 2.5% year over year to $8.64 billion in the third quarter, missing internal expectations. Growth has slowed for two quarters in a row, after rising more than 7% in the first quarter and last year's fourth quarter. The cardiovascular unit grew 4.3% to $2.31 billion. Its Abiomed business, bought in 2022 for $16.6 billion, fell 2.3% to $412 million. Tim Schmid, worldwide chairman of medtech, blamed lower patient volume after an unfavourable UK study of the Impella heart device. He called the setback temporary and said pressure also came from sales outside the US. J&J expects results from its PROTECT IV study of nearly 1,300 patients next year.
US stock futures were mixed on Tuesday as investors weighed a wave of earnings reports. Dow futures rose 0.9%, S&P 500 futures slipped 0.1%, and Nasdaq futures fell 0.7%. Memory stocks fell for a second day after a Chinese chipmaker, CXMT, said it had made a breakthrough in memory chip production. Roundhill Memory ETF fell more than 5% in premarket trading. UnitedHealth rose more than 2% after it earned an adjusted $4.69 per share on $112.69 billion in revenue, beating estimates. It raised its full-year earnings outlook to at least $20.50 per share. Goldman Sachs gained more than 3% on strong results. JPMorgan Chase, Wells Fargo, and Citigroup fell short in parts of their reports. Johnson & Johnson fell 2% after $25.40 billion in sales narrowly missed estimates, though it raised its full-year forecasts.
Johnson & Johnson (J&J) beat earnings estimates, but the Middle East conflict hurt its medical-device sales in the region. Chief financial officer Joe Wolk said Gulf states such as Kuwait, the UAE, and Saudi Arabia are shifting budgets towards defence. The conflict has not yet raised J&J's costs. Tremfya sales rose 68% to $2.4 billion, beating estimates of about $2.19 billion. Stelara sales, which face generic competition, fell 54% to $716 million, above expectations of $591 million. Darzalex sales rose about 16% to $4.24 billion, short of the $4.4 billion expected. J&J raised its full-year sales forecast to about $101.2 billion at the midpoint, from $101.1 billion. Its adjusted earnings midpoint rose to $11.10 per share from $11.04. Shares closed at $263.73 on Monday, up 27% this year.
Johnson & Johnson will report third-quarter results on October 13, before the market opens. Analysts expect earnings per share (EPS) to edge up to $2.82, and the company has beaten EPS estimates in each of the past four quarters. The healthcare group, valued at $622.84 billion, has seen its stock rise 36.8% over 52 weeks. Shares are down 8.1% from their September 2 high of $281.07. In the second quarter, sales rose 6.6% to $25.31 billion, and adjusted EPS climbed 4.7% to $2.90. J&J raised its 2026 adjusted EPS estimate from $11.55 to $11.68. Of 25 analysts, 14 rate the stock "Strong Buy." The consensus price target of $282.60 implies 9.3% upside.