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Job Description

We are seeking a highly skilled and detail-oriented CSV Project Manager to join our team. The successful candidate will be responsible for developing, executing and reviewing in/house and/or third-party supplied CQV documentation deliverables, specifications, plans, test protocols, summary reports, (E)TOPS for a new Active Pharmaceutical Ingredient (API) milling suite. This individual will manage internal and external CQV resources to achieve on-time completion of all in-scope deliverables. This will be an 18-month project with potential to extend on site in Groton, CT.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

- Bach Degree (Science or Engineering)

- 5+ years experience within CQV Project Management in a GMP Pharma Environment

- cGMP/GMP

- Microsoft Office - 21 CFR Part 11 - 210 and 211

- Small Molecule null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].