（Senior) Specialist - Filling/分装(高级)专员
About this opportunity
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
Principle Roles & Responsibilities / Accountabilities
Engineering Project Support and Operation Readiness:
● Participate in new facility design and construction, including but not limited to process design, FAT, SAT, IOPQ, smoke study, VHP, Isolator EMPQ, APS etc. to contribute to project delivery.
● Support the initial development and optimization of aseptic filling processes.
● Participate in the implementation of operation readiness, eg: draft equipment operation procedures and logbook, 5S, machine cleaning according to readiness plan.
● Trained and qualified on equipment operation and aseptic techniques.
● Perform other duties as assigned.
Routine Operation:
● Ensure routine operation in compliance with Roche’s GMP/SHE and regulation requirements.
● Performing the following tasks: e.g. vial washing, filling and stoppering, capping.
● Train new employees and enhance the professional capabilities of the team.
● Support environmental monitoring activities to ensure that the Isolatore environment meets aseptic standards.
● Handle deviations during production and implement CAPA.
● Diagnose and resolve equipment malfunctions promptly with the support of maintenance engineers to minimize downtime.
● Execute regular validation activities, such as APS.
● Ensure data accuracy, integrity, and traceability for the activities in the GMP area.
● Related IT system operations, such as SAP, MES, Veeva, Cornerstone.
● Perform other duties as assigned.
Qualification and Experience
Education/Qualifications
● College’s Degree (Pharmaceutical / Biological is preferred) and above.
Job Required Competencies
● 5 or more years’ operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred.
● Experienced in strategic projects of Aseptic Filling facility including design, commissioning & qualification，Isolator filling line is preferred.
● Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry.
● Fluent communications skills in English is preferred and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Job details
How this role compares
Computed from every other active Manufacturing & CMC role in our database, not just this employer's listings.
We currently track 373 comparable Senior Manufacturing & CMC roles across 53 biopharma companies.
Salary context
175 of 373 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 373 comparable roles
+ 14 more countries
Seniority mix
373 of 373 peers have a known seniority level
Therapeutic area mix
0 of 373 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.