Jürgen Schmickler - Manager Manufacturing Operations USP

Q: Where is Jürgen based?

Jürgen is based in Freienbach, Switzerland .

Q: What languages does Jürgen speak?

Jürgen speaks the following languages: German (Native), English (Advanced) .

Q: How many years of experience does Jürgen have?

Jürgen has at least 22 years of experience. During this time, Jürgen has worked in at least 17 different roles and for 16 different companies . The average length of individual experience is 1 year and 4 months . Note that Jürgen may not have shared all experience and actually has more experience.

Q: What is Jürgen's latest experience?

Jürgen's most recent position is Manager Manufacturing Operations USP at Thermo Fisher Scientific .

Q: What companies has Jürgen worked for in recent years?

In recent years, Jürgen has worked for Thermo Fisher Scientific , GETEC Swiss , Recipharm , Lonza , and Takeda .

Q: Which industries is Jürgen most experienced in?

Jürgen is most experienced in industries like Pharmaceutical , Beauty and Cosmetics , and Chemical . Jürgen also has some experience in Biotechnology , Manufacturing , and Healthcare .

Q: Which business areas is Jürgen most experienced in?

Jürgen is most experienced in business areas like Quality Assurance (QA) , Production/Manufacturing , and Project Management . Jürgen also has some experience in Operations , Sustainability Management , and Audit .

Q: Which industries has Jürgen worked in recently?

Jürgen has recently worked in industries like Pharmaceutical , Biotechnology , and Energy .

Q: Which business areas has Jürgen worked in recently?

Jürgen has recently worked in business areas like Production/Manufacturing , Quality Assurance (QA) , and Operations .

Recommended expert

Freienbach, Switzerland

Experience

Jan 2024 - Present

2 years 3 months

Lengnau, Switzerland

Manager Manufacturing Operations USP

Thermo Fisher Scientific

Liquida, aseptic/sterile, fill & finish, solida in production & packaging
CAPEX/Greenfield, 5kL SUT Owner, CVQ, runs/SCM/SCORE, SFM, KPI, CAD, CQV, MSAT, trainings, audits, EHS
Organization, construction, sterile production, operations, packaging, PPQ, Op-readiness, RM, audits, documentation authoring

Jan 2023 - Dec 2023

1 year

Muttenz, Switzerland

Senior Consultant / Senior Coacher IMS

GETEC Swiss

IMS, GMP, ISO 9001, 14001, 45001, 50001
Readiness/optimization, audits, re-certification

Jan 2023 - Dec 2023

1 year

Wasserburg am Inn, Germany

Head of Sterile Production/LdH AMWHV a.I.

Recipharm

Construction & CAPEX (lead > 100 FTE)
Fill & finish, lyo, product releases, FDA, Annex 1, lean, CQV, EHS
Commercial/clinical launch, scale-up, spin-off dosage forms

Jan 2021 - Dec 2022

2 years

Visp, Switzerland

Senior Consultant QC and VI DP Fill & Finish

Lonza

CAPEX/IBEX, VI/Knapp/AQL, CQV, MES, CCS
Liquida: aseptic F&F, RABS/isolator/lyo, VI, USP 5 kL Bio SUT, harvest, centrifugation, incubation, skids, COTS, HVAC, DQ-PQ/FAT/SAT, PPQ, media fill, AQL, PV, smoke studies, MSAT, VTOP/CTOP
Solida: granulator, coater, extractor, capsuling/compression

Jan 2021 - Dec 2021

1 year

Linz, Austria

Senior Consultant CAPEX F&F

Takeda

Process optimization, compliance, auditing, training

Jan 2020 - Dec 2020

1 year

Leverkusen, Germany

Acting Head of Operations, Fill & Finish

WuXi Biologics

Construction OpEx & CAPEX (lead > 30 FTE, 80 Mill.)
Corporate QA/QC, FvP/QP, QMB, RP 52a AMG, compliance officer
cGMP/GMP/GxP compliance, FDA readiness, MES, CQV, audits, inspections, transfers, DEV/CAPA/CC management, BRR, releases, trainings
Q-oversight, QMS systems, excellence

Jan 2019 - Dec 2019

1 year

Trittau, Germany

Acting Head of Manufacturing/LdH AMG/AMWHV

Panpharma

Board member/BU lead (> 180 FTE)
Aseptic F&F, releases, CQV/media fill, audits, EHS
Site EHS, EHS-MS/ASM, IMS systems, regulatory compliance, energy management, risk management, safety, sustainability

Jan 2018 - Dec 2019

2 years

Rankweil, Austria

Acting Head of Team Filling Solutions

Rentschler/RFS

Construction (lead > 40 FTE)
cGMP, OpEx, RABS/lyo, aseptic programs, CQV, MES, audits, EHS, certification, safety checks, trainings

Jan 2017 - Dec 2018

2 years

Mainz, Germany

Senior Consultant fill & finish/VI

BioNTech

Construction VI/Knapp, CQV, RABS systems
USP/DSP, cGMP/GMP, mRNA/vaccines, audit

Jan 2016 - Dec 2017

2 years

Freiburg im Breisgau, Germany

Acting Head QMB/Compliance Officer/RP 52a AMG

Alcon/Novartis

QMS/QM (lead > 6 FTE), new ISO 13485, MDR/IVDR, 9001, 14971, GMP, transfers, audits
CAPEX, IMS/QMS compliance, PMO, rollouts (agile/scrum), design, team building, evaluation, tracking/control, reporting, RM, PCC, closing, training
Construction/compliance/readiness programs, transfers, excellence (Lean/Six/SFM, Kaizen/PDCA, EFQM), CQV (DQ-PQ, PPQ, media fill)

Jan 2016 - Dec 2016

1 year

Schorndorf, Germany

Deputy Head of Production, Acting Head of Manufacturing (AMG/AMWHV)

Catalent

Led 160 FTE in solid dosage production
Compliance officer, FDA readiness/audit, BRR, MES, CQV, EHS

Jan 2014 - Dec 2015

2 years

Switzerland

Head of Quality / Acting Corporate Quality Manager & QP

Acino Pharma

Corporate Q-quality, site transfer (approx. 80 million CAPEX)
QMS, CQV, product releases, audits, EHS
IMS/QMS/EHS systems, process/product excellence

Jan 2013 - Dec 2014

2 years

Basel, Switzerland

QA Manager P-Technique & Delegated QP/FvP

Roche

O-oversight, IMP CQV (URS, DQ-PQ, PPQ, ECC)
cGMP/GMP compliance, FDA readiness, RA/FMEA, audits
Regulatory interactions (FDA, EMA, Swissmedic, ANVISA, CFDA, KFDA, TPD, SFKN, CMDCAS)
API/commercial/aseptic filling, analytics

Jan 2011 - Dec 2013

3 years

Kundl, Austria

Senior Consultant/Projects/QA & QC/Production

Sandoz

PL SELS, FDA inspections, QMS/SOPs, DEV/CAPA/CC management
RABS/USP/DSP, transfers

Jan 2011 - Dec 2012

2 years

Baar, Switzerland

Senior QA Manager & Acting QP/FvP

J&J/Janssen-Cilag

MES/PAS-X/AI 4.0/Siemens/Rockwell, ERP, Kneat, EBR, COMOS
QA lead (6 FTE), BRR/QP releases, PQR, cGMP/GDP, CAPA/RM, QMS, audits, trainings

Jan 2009 - Dec 2010

2 years

Mannheim, Germany

Site Head EHS (Interim) & Compliance Officer

Alstom

Site board member/EHS (lead 8 FTE)
EHS compliance, SCC/14001/18001, risk management, EHS audits, trainings, excellence road map

Jan 2004 - Dec 2008

5 years

Independent SME, Project Manager & Senior Advisor

Lead projects in chemical parks, IMS/QMS/QA/QC, REACH, EHS, EFQM, cGMP/GMP, audits
Provide strategic, holistic, pragmatic solutions with clarity, creativity, transparency and structure
Act as ambassador for sustainable excellence
Clients: dalli, Cognis, Jowat, Martinswerk, Ineos, Fresenius, P&G, Cosmopolitan Cosmetics, Mäurer, EU Commission, Hüttenes Albertus, Deutsche Steinkohle, Johnson & Johnson

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Pharmaceutical (20 years), Biotechnology (5 years), Cosmetics (5 years), Chemical (5 years), Manufacturing (3 years), and Healthcare (2 years).

Pharmaceutical

Biotechnology

Cosmetics

Chemical

Manufacturing

Healthcare

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (22 years), Production (13 years), Project Management (10.5 years), Operations (10 years), Sustainability Management (6 years), and Audit (2 years).

Quality Assurance

Production

Project Management

Operations

Sustainability Management

Audit

Summary

As a Chemist, SME, Interim Manager, Senior Consultant, Lead Auditor and Trainer, I have extensive experience in Pharma, Biotech, MedTech and Chemistry since 1993. My key competencies are manufacturing/operations, quality and EHS. My expertise in leadership, analysis, problem-solving and teamwork, along with my soft skills, are the foundation for my successful projects and roles at, among others, global players, start-ups, mid-sized companies, MAHs/CDMOs and chemical parks, meeting requirements in the D-A-CH region, EU, US, Asia, South America and beyond.

Skills

Manufacturing/production/operations (Liquid, Aseptic/sterile, Fill & Finish, Solid In Production & Packaging):

Organization, Construction, Sterile Production, Operations, Packaging, Scm/score, Sfm, Kpi, Cad, Cqv, Msat, Trainings, Audits, Ehs, Etc.
F&f (A-e): Vials, Syringes/injections, Ampules, Combinations, Etc.
Bulks (Among Others): Vials, Granulates, Tablets, Powder, Etc.
Products (Commercial/clinical, Launch, Scale-up, Spin-off Dosage Forms): Biologics/bioconjugates, Cho/expicho, (M)rna/recombinants, Antivirals, Vaccines, Plasmids, Oncology, Penicillin, Api, Imp, Ds, Sm/lm, Atmp, Btm, And/ind, Otc, Generics, Mdr/ivdr, Etc.
Fine Chemicals, Cosmetics, Plastics, Hc, Detergents, Adhesives, Etc.

Technique (Biotech, F&f/liquid, Solid):

Liquid: Aseptic F&f, Rabs/isolator/lyo, Vi, Usp 5 Kl Bio Sut, Harvest, Centrifugation, Incubation, Skids, Cots, Hvac, Cqv, Vtop/ctop, Dq-pq/fat/sat, Ppq, Media Fill, Aql, Pv, Smoke Studies, Mes, Msat, Etc.
Solid: Granulator, Coater, Extractor, Capsule/compression, Etc.

Quality (Corporate, Qa/qc, Fvp/qp, Qmb, Rp 52a Amg, Compliance Officer):

Construction, Organization, Q Oversight, Qms Systems, Excellence, Cgmp/gmp/gxp Compliance, Inspections, Audits, Cqv, Etc.
Rm, Dev/capa/cc Management, Brr, Releases, Trainings, Etc.
Qc/analytics, Methods, Lean Lab, Mibi, Aql, Transfer Projects, Etc.

Ehs & Reach (Site Ehs, Ehs-ms/asm, Ims-systems, Regulatory Compliance, Energy):

Safety Organization, Risk Management, Ehs Compliance/oversight, Excellence/sustainability, Process Safety, Representation, Etc.
Inspections, Ehs Audits, Certification, Safety Checks, Trainings, Etc.

Regulatory Basics (Among Others):

Fda, Ema, Swissmedic, Anvisa, Cfda, Kfda, Tpd, Sfkn, Cmdcas, Regional/rp/inspectorates And Authorities
Cgmp/210/211/820/etc., Ich (Q7, Q8, Q9, Q10, Etc.), Gmp, Annex 1, 2, 15, Etc., Aide-mémoires, Pic/s, Ispe, Iso (14644, 14971, 15378, Etc.)
Iso 9001/efqm, 14001, 45001, Scc, 18001, 13485, 14971, Etc.
52a Bimschg, 16. Bimschv, Betrsiv, Lmg/lmgb, Reach, Etc.

It (Among Others):

Mes/pas-x/ai 4.0/siemens/rockwell, Erp, Kneat, Ebr, Comos, Etc.
E-dms, Mastercontrol, Documentum, Trackwise, Lims, Etc.
Ms Office/project, Sap, Office 365, Ennov, Biomedion, Etc.

Soft Skills (Self-assessment):

My Skills And Leadership Passion For Sustainable Solutions, Potential Development And Excellence, My Strategic, Holistic And Pragmatic Approach
My Clarity, Creativity, Transparency And Structure In Teamwork, In My Results And In My Communication
My Drive To Be A Convincing Ambassador For Success.

Languages

German

Native

English

Advanced

Education

Oct 1990 - Jun 1992

University of Cologne

Doctor of Natural Sciences · Life Science · Cologne, Germany

Oct 1981 - Jun 1990

University of Cologne

Master of Chemistry · Chemistry · Cologne, Germany

Oct 1971 - Jun 1980

Dreikönigsgymnasium

Swiss Matura · Cologne, Germany

...and 1 more

Certifications & licenses

New ISO 13485, MDR/IVDR

Referent FDA Q-Oversight

Concept Heidelberg

QP/FvP Pharma/BioTech

Konzept Heidelberg

PM & Senior Trainer Chemical Parks

BG Chemie

SME TÜV VAwS, SME REACH & Only Representative

Senior Lead Auditor (ISO, GMP/FDA, EHS, QMS, etc.)

VCI Executive Referent

VCI

TGA EHS Auditor, EOQ Auditor & Manager

DGQ Professional Auditor, GMP Auditor, SME QMS

Profile

Created

July 2025

Last Update

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Jürgen based?

Jürgen is based in Freienbach, Switzerland.

What languages does Jürgen speak?

Jürgen speaks the following languages: German (Native), English (Advanced).

How many years of experience does Jürgen have?

Jürgen has at least 22 years of experience. During this time, Jürgen has worked in at least 17 different roles and for 16 different companies. The average length of individual experience is 1 year and 4 months. Note that Jürgen may not have shared all experience and actually has more experience.

What roles would Jürgen be best suited for?

Based on recent experience, Jürgen would be well-suited for roles such as: Manager Manufacturing Operations USP, Senior Consultant / Senior Coacher IMS, Head of Sterile Production/LdH AMWHV a.I..

What is Jürgen's latest experience?

Jürgen's most recent position is Manager Manufacturing Operations USP at Thermo Fisher Scientific.

What companies has Jürgen worked for in recent years?

In recent years, Jürgen has worked for Thermo Fisher Scientific, GETEC Swiss, Recipharm, Lonza, and Takeda.

Which industries is Jürgen most experienced in?

Jürgen is most experienced in industries like Pharmaceutical, Beauty and Cosmetics, and Chemical. Jürgen also has some experience in Biotechnology, Manufacturing, and Healthcare.

Which business areas is Jürgen most experienced in?

Jürgen is most experienced in business areas like Quality Assurance (QA), Production/Manufacturing, and Project Management. Jürgen also has some experience in Operations, Sustainability Management, and Audit.

Which industries has Jürgen worked in recently?

Jürgen has recently worked in industries like Pharmaceutical, Biotechnology, and Energy.

Which business areas has Jürgen worked in recently?

Jürgen has recently worked in business areas like Production/Manufacturing, Quality Assurance (QA), and Operations.

What is Jürgen's education?

Jürgen holds a Doctorate in Life Science from University of Cologne and a Master in Chemistry from University of Cologne.

Does Jürgen have any certificates?

Jürgen has 9 certificates. Among them, these include: New ISO 13485, MDR/IVDR, Referent FDA Q-Oversight, and QP/FvP Pharma/BioTech.

What is the availability of Jürgen?

Jürgen is immediately available full-time for suitable projects.

What is the rate of Jürgen?

Jürgen's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.