Validation Specialist (12개월 계약직, 2년 이상 유관 경력자, 제약/바이오)
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여러분만의 특별한 재능으로 머크와 함께 마법을 펼쳐보세요!
커리어 여정을 계속해서 탐험하고, 발견하고, 도전할 준비가 되셨나요? 커리어에 대한 열정으로 가득한 여러분처럼, 머크도 거대한 포부로 가득하답니다! 머크의 전 세계에 있는 구성원들은 과학 기술의 혁신으로 헬스케어, 생명과학, 그리고 전자소재 부문에서 사람들의 삶을 풍요롭게 만들고 있습니다. 머크의 구성원들은 한마음이 되어 고객, 환자, 인류, 더 나아가 지구의 지속 가능함을 위해 힘쓰고 있습니다. 그것이 바로 머크가 호기심 가득한 인재를 원하는 이유랍니다, 호기심은 모든 것을 상상할 수 있게 만드는 원동력이니까요.
Your role:
The Validation specialist role will perform site qualification& validation and ensure that qualification& validation activities consistently comply with all regulatory and corporate requirements in support of regulatory requirements and customer expectations.
This position will also entail validation Management system operation and maintenance, to ensure the system compliance with all Domestic and Global regulatory and corporate requirements.
Ensure validation employees are hired, trained, and qualified to support project execution and conduct daily operational activities.
Develop site validation management procedures for equipment qualification, computerized system validation, process validation, cleaning validation, transportation verification, and HVAC/Clean Utilities ensure that site validation management procedure complies with regulatory requirements and global standards.
Prepare Validation Master Plan, Validation Plans for Equipment qualification, process and cleaning validation, and Computerized Systems (PCS, MES, EMS, WMS, ASRS, LIMS) in place on schedule in collaboration with Subject Matter Experts.
Conduct site qualification& validation, ensure that processes, procedures, equipment, facility, systems and methods are validated, and ensure that qualification& validation activities consistently comply with GxP/ISO regulatory requirements, corporate standards and customer expectations.
Collaborate process owner/relevant dept for validation activities such as URS, risk assessment, FAT/SAT document review, validation protocol/report preparation, and execute DQ/IQ/OQ/PQ including test execution witness and result review.
Carry out periodic validation status review and perform site requalification and revalidation.
Who you are:
Minimum bachelor’s degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, or a related discipline.
+ 2 years in the pharmaceutical, biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
Experience in handling sterile product required.
Experience in developing CCS and APS/APV preferred.
Good communication in English.
Good decision-making and problem-solving capability
•여러분이 찾고 계시는 채용 포지션이 없으신가요? 그렇다면 인재풀(클릭) 에 여러분의 이력서를 등록해주세요! 향후 인력 수요가 있을 경우 최우선으로 안내드리겠습니다.
•지원 순으로 전형이 진행되며, 적합한 후보자 발견 시 채용이 바로 마감되오니 지원의사가 있으신 분들은 빠른 지원 바랍니다.
•서버 안정성을 위해, 인터넷 익스플로러가 아닌 구글크롬, 혹은 마이크로소프트 엣지를 통한 지원 바랍니다.
•보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.
•지원서의 기재사항이 사실과 다른 것으로 확인되거나 Reference from previous employer 상에 채용상의 결격사유가 확인될 경우 합격 또는 채용이 취소될 수 있습니다.
•(The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application. The offer is conditional upon satisfactory results of reference checks.)
•"머크 코리아 채용" 카카오톡 페이지와 친구를 맺어 최신 채용 소식을 받아보세요! (카카오톡에 '머크 코리아 채용'검색 후 친구추가)
우리가 제공하는 것: 우리는 다양한 배경, 관점, 그리고 삶의 경험을 가진 호기심 많은 인재들입니다. 이러한 다양성이 탁월함과 혁신을 이끌어내며, 과학과 기술 분야에서 우리의 리더십을 강화한다고 믿습니다. 우리는 모든 이가 자신의 속도에 맞춰 발전하고 성장할 수 있는 기회와 접근성을 제공하는 데 집중하고 있습니다. 우리와 함께 포용과 소속의 문화를 구축하여 수백만 명에게 긍정적인 영향을 미치고, 모두가 인류의 발전을 이끌 수 있도록 합시다!
지금 지원하여 발견을 이끌고 인류를 발전시키는 팀의 일원이 되어 보세요.
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1008 comparable Quality roles across 131 biopharma companies.
Salary context
193 of 1008 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1008 comparable roles
+ 42 more countries
Seniority mix
498 of 1008 peers have a known seniority level
Therapeutic area mix
2 of 1008 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
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.
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How we calculate "similar"
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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.