Job Description

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Position Purpose

The main responsibilities of this position are:

Involved in all GMP aspects of the execution of commissioning and qualification activities, ensuring quality, working closely with the Engineering Services as well CVQ to deliver innovative qualified facilities, utilities and equipment, ready for commercial production. Active involvement in issue assessment and management, especially in collaboration with Engineering and CVQ. Continuously improving quality standards for assigned quality systems and relevant production areas. The role supports and encourages active knowledge management within the assigned department and drive continuous improvement processes.

Position Relationships

The position reports to:

Manager QM Qualification - Lengnau

The position interacts with:

Quality Management, QC and other QA functions, Lengnau Manufacturing Science & Technology (MSAT), Lengnau Drug Substance Manufacturing, Lengnau Execution Systems, Lengnau Engineering & Facilities, Lengnau

Position Responsibilities & Accountabilities

Technical Responsibilities

QA representative for C&Q activities in any assigned C&Q team. Ensures as QA representative the compliance Quality of all elements (e.g. URS, QRA) leading to C&Q activities (DQ, IQ, OQ, and PQ). Review and approves C&Q system specific documentation TURS, RTM, QRA, IOC - if applicable, IQ, OQ, PQ, QR according to internal standards. Assess and reviews punches, project deviations occurred on assigned systems during C&Q phase Establish basic documents (SOPs, WIs, etc..) based on request governing C&Q under the supervision of the direct manager within the reporting line.

Quality

Follows cGMP rules, quality policies, procedures and instruction as rolled out by the quality function and endorsed by the site management. Actively participates in quality improvement initiatives and deviation reporting and follow-up.

EHSS

Adheres to general safety rules. Proactively supports safety initiatives and issues as well as near miss.

Values & behavior

Maintains dedication to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards. Takes personal accountability for their presence, performance, and efficiency for the achievements of defined objectives. Thinks and acts with a customer-centric approach. Is intellectually curious and accepts practical process improvement (PPI).

Position Qualifications

Education

Degree (Bachelor or Masters) in Engineering or Life Science (Biology, Chemistry, etc.) Dipl. or M.Sc. Or B.Sc.

Experience & competences

Qualification experience preferably gained on a Life Sciences / Pharma / Biotech Upstream / Downstream facility. Several years of successful commissioning and/or qualification experience on midsized and major projects with high complexity in the chemical, biotech or pharmaceutical industry. Confirmed experience in cGMP, Qualification and Quality Risk Management. Language: proficient in English and preferably in German required. Excellent time management skills, with the flexibility to handle changing priorities and multiple tasks.

Additional requirements

* N/A