MSAT Associate Principal Scientist

Eupro AG; Visperterminen; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Eupro AG in Viège (Valais) seeks an experienced MSAT Associate Principal Scientist to lead validation strategies for biopharma processes. The role covers validation planning, execution, data review and regulatory liaison in a fast-paced MSAT environment across R&D, QA and Production.

Ideal candidates will have 5–10 years in biopharma, strong GMP knowledge, and hands-on experience with process validation lifecycle, deviations, CAPA and risk analysis. English fluency is required; French is a plus.

Qualifikationen

• University degree in Biotechnology, Biology, Biochemical Engineering, Microbiology or related field.
• 5–10 years in biopharma.
• Proven experience in Process Validation and/or MSAT.
• Strong knowledge of the process validation life cycle.
• Proficiency in GMP, FDA, EMA and ICH expectations.
• Experience in deviation management, CAPA, Change Controls and risk analysis.
• Ability to analyze complex validation data and train junior staff.
• Excellent English; French is a plus.

Aufgaben

• Write and manage process validation activities (plans, protocols, reports).
• Provide technical support to the R&D and MSAT teams during characterization and validation phases.
• Review and approve process characterization and validation documentation.
• Assess the impact of change controls and deviations on the validated status of processes.
• Set up and maintain the CPV program.
• Participate in multidisciplinary risk analyses (FMEA, risk assessments, etc.).
• Analyze validation data and oversee investigations in case of discrepancies.
• Represent validation expertise during client audits and regulatory inspections.
• Collaborate with QA for batch release during validation campaigns.
• Train and supervise junior employees in validation/MSAT.

Kenntnisse

Process validation

MSAT

GMP compliance

Regulatory knowledge

Deviation management

CAPA

Change controls

Risk analysis

Data analysis

Cross-functional collaboration

Project management

Training supervision

English communication

Ausbildung

Bachelor/Master/PhD in Biotechnology or related field

Jobbeschreibung

Expert in the validation of biopharmaceutical processes? We are looking for an experienced MSAT and Process Validation professional to ensure the implementation and maintenance of validation strategies compliant with international GMP and regulatory requirements.

-Temporary position

-Duration : 8 months

-Location : Viège (Valais)

MSAT Associate Principal Scientist

Primary responsibilities

• Write and manage process validation activities (plans, protocols, reports).
• Provide technical support to the R&D and MSAT teams during the characterization and validation phases.
• Review and approve process characterization and validation documentation.
• Assess the impact of change controls and deviations on the validated status of processes.
• Set up and maintain the Continued Process Verification (CPV) program.
• Participate in multidisciplinary risk analyses (FMEA, risk assessments, etc.).
• Analyze validation data and oversee investigations in case of discrepancies.
• Represent the validation expertise during client audits and regulatory inspections.
• Collaborate with QA for batch release during validation campaigns.
• Train and supervise junior employees in validation/MSAT.

Profile

• University degree (Bachelor, Master or PhD) in Biotechnology, Biology, Biochemical Engineering, Microbiology or related scientific field.
• Minimum 5 to 10 years of experience in the biopharma industry.
• Confirmed experience in Process Validation and/or MSAT (Manufacturing Science & Technology).
• Strong knowledge of the process validation life cycle
• Experience in the development and transfer of biopharmaceutical processes.
• Proficiency in GMP requirements and FDA, EMA and ICH regulatory expectations.
• Experience in deviation management, CAPA, Change Controls and risk analysis.
• Ability to analyze and interpret complex validation data.
• Knowledge of cell culture and/or purification processes for biomolecules.
• Experience in drafting and reviewing protocols, validation reports and technical documents.
• Strong ability to work in a cross-functional environment (MSAT, QA, Production, QC, R&D).
• Excellent project management, organizational and prioritization skills.
• Ability to train, support and supervise more junior employees.
• Analytical mind, scientific rigor and quality orientation.
• Very good communication skills in English; knowledge of French is an asset.